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Number To Know is a new regular feature by Medtech Insight, highlighting data sourced from Meddevicetracker, Informa’s medtech intelligence product.


Total worldwide sales of heart valve disease treatment systems are expected to grow at a compound annual growth rate of 10.9% by 2021.

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Global sales of heart valve repair and replacement devices -- which include surgical heart valve replacement, surgical heart valve repair, percutaneous balloon valvuloplasty, transcatheter aortic valve replacement and transcatheter mitral valve repair systems – are expected to expand from $4.8bn in 2016 to $8.1bn by 2021, a CAGR of 10.9%.

Globally, the US will continue to see the biggest market share, and emerging transcatheters will see the biggest growth opportunity worldwide.

For more details on the heart valve disease and replacement devices market, read the newest Meddevicetracker report here.

 

*Source Meddevicetracker  10/07/2017

 
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With a contribution from the Innovation Network Corporation of Japan, Konica Minolta – the Japanese conglomerate better known for its printers and copiers – agreed to pay $1bn for Ambry Genetics as the first part of planned precision medicine platform.

 

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Konica Minolta Inc. and Innovation Network Corporation of Japan, a public-private investment company that invests in innovative businesses, will pay $800m for Aliso Viejo, Calif.-based Ambry Genetics, with another $200m due Ambry shareholders pending the achievement of certain metrics over the next two years, the companies announced July 6.

Konica Minolta will invest 60% and INCJ will account for the remaining 40%, making Ambry part of Konica Minolta Healthcare Americas Inc., a wholly owned subsidiary of Konica Minolta.

The deal will lead to the creation of a "comprehensive set" of diagnostic technologies for mapping an individual's genetic and biochemical makeup, the firms say, and help make Konica Minolta a leader in precision medicine – especially in Japan.

Check out the story here.

 

*Source Meddevicetracker  06/07/2017

 
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52% of EU citizens want access to their health data – of which 70% are willing to share it, while 23% don't want to.

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Ain Aaviksoo, Estonia's Ministry of Social Affairs' deputy secretary-general for e-services and innovation, told Medtech Insight that 52% of EU citizens want access to their health data. Of that number, 70% are willing to share it, while 23% don't want to.

Estonia is making improvements to digital health one of the priorities for its term in the European Union Council presidency, which runs July through December. Estonia wants to take the "next step toward the digital health society," Aaviksoo said in a July 4 presentation. "The future will most probably be digital, so a prosperous EU should embrace digital transformation."

Check out the article here.

 

*Source Meddevicetracker  06/07/2017

 
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1 is the number of medical device-related guidances that US FDA has published since the Trump administration took the reins of power.

 

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It's been more than six months since President Trump entered the White House with the promise of deregulating federal agencies. That promise seems to be holding up, especially when it comes to the US FDA.

Since Jan. 20 the agency has released only one guidance – on electronic records and signatures in clinical trials – that affects the medical device industry. Click here to read about that guidance.

 

*Source Meddevicetracker  05/07/2017

 
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5 is the number of device-related close-out letters released by US FDA in June.

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US FDA released 5 device-related close-out letters last month. The agency's close-out program publicly indicates when a manufacturer has addressed agency concerns outlined in a warning letter.

Check out Medtech Insight's June close-out chart here.

 

*Source Meddevicetracker  04/07/2017

 
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Costa Rica's medical device firms rung up $2.2bn in sales in 2015, making devices the country's No. 1 export.

 

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It may be surprising to some that medical devices are Costa Rica's No. 1 export, and the country is the No. 2 exporter of devices in Latin America. In fact, according to CINDE – the Costa Rican Investment and Trade Development Board – exports of devices grew at an average annual rate of 14.3% between 2005 and 2015, from $580m in sales in '05 to $2.2bn in '15.

Check out Medtech Insight's recent feature story here on how quality assurance experts from a variety of firms in Costa Rica – including Medtronic, Precision Concepts and Creganna Medical – have banded together to lean on each other as they search for solutions to quality systems issues, as well as knowledgeable input on hot quality and compliance topics.

 

*Source Meddevicetracker  03/07/2017

 
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The Device Week podcast has reached its 100th episode. Each week, Medtech Insight journalists discuss key news and analysis impacting the device and diagnostics space.

 

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100 is the number of Device Week podcasts that have been produced by Medtech Insight. Device Week launched in June 2015 to provide a weekly roundup of important news and analysis for the medical device and diagnostics sectors from our expert journalists.

Check out the 100th episode of Device Week here, and you can access more episodes of the podcast here.

 

*Source Meddevicetracker  30/06/2017

 
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38.50 is the amount in US dollars per share that Royal Philips Electronics NV will pay to acquire all of the issued and outstanding shares of Spectranetics Corp. It represents a 27% premium over Spectranetics closing price on June 27, 2017. The implied enterprise value is approximately $2 billion, inclusive of Spectranetics’ cash and debt. The transaction is expected to close in the third quarter of 2017.

 

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Philips says the acquisition of Spectranetics will further expand and strengthen its Image-Guided Therapy Business Group. Spectranetics is a leader in vascular intervention to treat coronary and peripheral artery disease, and in lead management for the minimally invasive removal of implanted pacemaker and implantable cardioverter defibrillator leads. Spectranetics is currently growing by double digits and projects 2017 sales to be in the range of $293 million-$306 million.

Meddevicetracker subscribers can access a full analysis of Royal Philips and Spectranetic's product portfolios.

*Source Meddevicetracker  29/06/2017

 
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There have been 2 patients who have improved from sensory-incomplete "AIS B" spinal cord injury (SCI) to motor-incomplete "AIS C" SCI in InVivo Therapeutics' INSPIRE study of the Neuro-Spinal Scaffold.

 

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2 is the number of patients in InVivo Therapeutics' INSPIRE study that have improved from sensory-incomplete "AIS B" spinal cord injury (SCI) to motor-incomplete "AIS C" SCI in the firm's most recent assessment. These are the second and third patients in the INSPIRE study to have reached AIS C motor incomplete classification.

The INSPIRE trial is studying the impact of InVivo's Neuro-Spinal Scaffold on patients with complete paralysis due to thoracic injury.

Meddevicetracker subscribers can access a full analysis of InVivo Therapeutics' product portfolio, including the clinical and regulatory status of the Neuro-Spinal Scaffold, here.

*Source Meddevicetracker  28/06/2017

 
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Thermo Fisher Scientific's Oncomine Dx Target Test is designed to evaluate simultaneously 23 genes associated with non-small cell lung cancer; it is the first of its kind to be approved by the US regulatory watchdog.

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23 is the number of non-small cell lung cancer- related genes that Thermo Fisher Scientific's recently US FDA-approved Oncomine Dx Target Test is able to simultaneously evaluate. Following the premarket approval, results from analysis of three of these genes can now be used to identify patients who may be eligible for treatment with one of the following: the combined therapy of Tafinlar and Mekinist, Xalkore, or Iressa. With this test, physicians can now match patients to these therapies in days instead of several weeks, which it often takes when screening samples one biomarker at a time.

Meddevicetracker subscribers can access a full analysis of Thermo Fisher Scientific's product portfolio including the clinical and regulatory status of the Oncomine Dx Target Test here.

*Source Meddevicetracker  27/06/2017

 
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25 is the number of different types of software that make up Virtually Better's top-of-the-line virtual reality system used as exposure therapy to treat phobias, addictions and other mental health disorders.

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Virtually Better Inc.'s top-of-the-line virtual reality system currently used in exposure therapy for treating mental health disorders comprises 25 different types of software. Among this suite of software is Bravemind for post-traumatic stress disorder; it is designed to recreate in a virtual world the most traumatic experiences that patients from the military have encountered during combat situations. Virtually Better Inc., is one of a growing number of companies that are driving the adoption of VR and gaming technologies in the realm of health care.

To find out more about other types of VR-related health applications and technologies, read Medtech Insight's market intelligence feature on this topic.

 

*Source Meddevicetracker  26/06/2017

 
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Anova Cancer Care Center in Colorado this month treated its 1,500th prostate cancer patient with the robotic radiation therapy device CyberKnife, from Accuray.

 

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1,500 is the patient-treatment milestone recently achieved at Anova Cancer Care Center, located in Lone Tree, Colorado, using Accuray, Inc.'s CyberKnife, a noninvasive, fully robotic radiation therapy device designed to deliver stereotactic body radiation therapy (SBRT). SBRT is a highly precise form of radiation therapy which maximizes dose to the tumor and minimizes dose to surrounding healthy tissue.

 

Meddevicetracker subscribers can access a full analysis of Accuracy's product portfolio including the clinical and regulatory status of the CyberKnife System here.

*Source Meddevicetracker  23/06/2017

 
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70.4% of patients in the Avalon study of Saluda Medical's closed-loop spinal cord stimulation device reported an 80% or more reduction in back pain relief, three months after implantation. Saluda recently raised $40m in new financing to support further clinical trials of its Evoke system.

number to know 704

 

Three-month follow-up data in the first long-term study of Saluda Medica's Evoke closed-loop spinal cord stimulation device showed that 70.4% of patients reported an 80% or more reduction in back pain relief. At six months, 65% of patients reported >80% reduction in back pain relief. Unlike conventional SCS devices, which delivers a fixed dose of electrical stimulation to the nerve over a programmed time, Evoke monitors the neural response to the electrical stimulation using data called evoked compound action potentials and automatically adjusts the therapeutic dose of stimulation based on this feedback. Saluda has just completed a Aus$53m ($40m) series D financing to support this ongoing long-term study and also a US pivotal trial.

To find out more about the results of the Avalon study and the forthcoming pivotal trial, as well as who the new investors in Saluda are, read Medtech Insight's article here.

 

*Source Meddevicetracker  05/06/2017

 
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At least 26 users of Abbott's Heart II heart assist device have died while trying to change the system's controller themselves at home. The product is now part of a class I recall.

number to know 26

 

Abbott Labs' Heartmate II left ventricular assist systems have been linked to at least 26 deaths after these patients tried to change the controllers of the device by themselves at home, the US FDA said in a recall announcement. These pocket controllers power the HeartMate II via a lead under the skin. They can run on battery or connect to a main power supply; patients are given a back-up controller in case the original sounds an alarm or malfunctions. Abbott said it received reports of 70 adverse events, including 19 injuries and 26 deaths, which are related to problems that arise when patients try to swap to the backup controller at home instead of going to a hospital, FDA says.

To find out more about this class I recall, read Medtech Insight's article here.

 

*Source Meddevicetracker  05/06/2017

 
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Investigators from the MAVERIC study reported a 30-day 100% device success rate for MVRx's ARTO System device for patients with heart failure.

 

 
 

 

100% is the device success rate reported in the final results of MVRx's MAVERIC study to evaluate the ARTO System at 30 days.

The ARTO System, a proprietary implantable device, is designed to improve heart failure symptoms by reducing mitral valve regurgitation – which is the backward leakage of blood through the mitral valve – thereby increasing the forward flow of blood to the rest of the body. As a result, the heart functions more effectively and efficiently, leading to improved circulation, breathing, and exercise tolerance. In the MAVERIC study, researchers found no instances of coronary artery compression and found patients experienced a significant reduction in mitral valve regurgitation and a significantly improved New York Heart Association heart-failure functional classification.

Meddevicetracker subscribers can access a full analysis of MVRx's product portfolio, including the clinical and regulatory status of the ARTO System. Not a subscriber? Click here to request your free demo.

 

*Source Meddevicetracker  05/06/2017

 
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Diagnostics firm Alere will be facing EU notified-body oversight for about 96% of its new-product files under the rules of the oncoming IVD Regulation in Europe. That will be a massive switch from the approximately 8% of files that currently require such a check.

number_to_know_ 96 

 

96 is the percentage of new-product files that a large diagnostics firm like Alere Inc. will need to have reviewed by a notified body before entering the market under the EU IVD Regulation, which is set to take full effect in 2022.

That's a massive switch from the approximately 8% of files that currently require such a check at Alere, according to Simon Richards, Alere's VP for regulatory affairs for Europe-Middle East. The other 92% of files currently enter the market based on a self-declaration from the company.

Read more coverage from the spring meeting of the British In Vitro Diagnostics Association (BIVDA) in this Medtech Insight article, and this one. Also: check out details and timelines for the implementation of the IVD Regulation, as well as the new Medical Device Regulation.

 

*Source Meddevicetracker  05/06/2017

 
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The cost of a bare metal stent in India is capped at INR7,260, after the country's National Pharmaceutical Pricing Authority clamped down on pricing for certain medical devices in February. These imposed pricing limits have been a bone of contention for medtech importers and more trouble is expected.

 

 

 

INR7,260 (or roughly US$112) is the current price at which bare metal stents are capped in India, as set out by the National Pharmaceutical Pricing Authority in February. Coronary stents have been the subject of a recent clampdown by the Indian government to rein in the cost of medical devices, many of which are imported. This has led to attempts by multinationals like Abbott, Medtronic and Boston Scientific to pull out certain stent brands from the Indian market. More recently, the NPPA has also been gathering data to monitor price movement of 19 medical devices, amidst rising concerns and fear among manufacturers.

To find out what's been going on with India's price control efforts and what other turbulence there is ahead, read Medtech Insight's article here.

 

*Source Meddevicetracker  05/05/2017

 
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Medtronic has initiated the pivotal study of its In.Pact AV Access drug-coated balloon and expects to enroll 330 patients.

number_to_know_ 330

 

 

330 is the total number of patients Medtronic expects to recruit for the IDE study of its In.Pact AV Access drug-coated balloon. The company announced May 24 that the first patient had been enrolled in the study, which will evaluate the safety and efficacy of the DCB as a treatment for failing arteriovenous fistulas in patients with end-stage renal disease. Evaluation will take place for up to two years, at approximately 30 sites in the US, Japan, and New Zealand. The patients will be randomized to receive treatment either with the In.Pact AV Access DCB or with standard PTA. The primary efficacy endpoint is patency of dialysis fistulas through six months and the primary safety endpoint is serious adverse events through 30 days.

 

Subscribers of Meddevicetracker can see more details of the study, and of Medtronic's portfolio of products, here.

Not a subscriber, click here to request your free demo 

 

*Source Meddevicetracker  05/05/2017

 
Not a subscriber, click here to request your free demo.

 


 
 

Medtronic cornered a 30.2% share of the global implantable spinal cord stimulator (SCS) market in 2016, making it the leading player in this space. The company is expected to continue to lead the SCS market, but is facing rising competition.

number to know 302

 

30.2% is Medtronic's share of the global implantable cord stimulator (SCS) market, based on the company's sales of $535.3m. Boston came in as the second leading player, followed by St Jude Medical, which is now part of Abbott. Medtronic and the other SCS heavyweights are facing rising competition in this market segment from existing and emerging companies developing ever more innovative and targeted therapies.

 

To learn more about the competitive landscape in the SCS market, read Medtech Insight's article here. The article is based on the new Meddevicetracker report, "Pain Management Devices Market".

 

*Source Meddevicetracker  05/05/2017

 
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Five years after the European Commission put out the first texts for the EU Medical Device and IVD Regulations, the final and agreed version of the new rules have now been published in the Official Journal of the European Union.

 

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5 is the number of years it has taken for the European Commission's proposed new framework for regulating medical devices and IVDs to pass through the rounds of negotiation with the European Parliament and Council of the European Union before they were finally adopted. 5 also represents 5/5, May 5, the date that the finalized versions of the EU Medical Device Regulation and the IVD Regulation were published in the Official Journal of the European Union.

Go to Medtech Insight to get our comprehensive coverage of the new EU regulations, from the day the first texts were made public on Sept 26 2012 until the publication in Journal of the final version on May 5.

 

*Source Meddevicetracker  05/05/2017

 
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56% is the stake that Theraclion has in a Chinese joint venture it has recently set up to sell its Echopulse high-intensity focused ultrasound system.

 

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French echotherapy specialist Theraclion SAS will take a 56% stake in a China-based joint venture it is setting up with one of its own shareholders, Chinese healthcare company Inner Mongolia Furui Medical Science Co. Ltd. Theraclion China Co, Ltd., to be based in the southern city of Shenzhen, will sell the Theraclion's Echopulse system, designed as a noninvasive alternative to surgery by excising benign thyroid nodules and removing breast fibroadenoma using high-intensity focused ultrasound (HIFU). According to Theraclion, China is the "biggest addressable market" for the company's products, as it represents over 50% of surgeries for benign thyroid nodules and breast fibroadenoma. The JV partnership, announced in April, was one of the deals recorded by Strategic Transactions and listed in Medtech Insight's bi-monthly Pacts In Medtech series.

To access Strategic Transactions deals database, click here.

To access March/April's edition of Pacts In Medtech, click here.

 

*Source Meddevicetracker  05/05/2017

 
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Teleflex's Arrow AC3 Optimus Intra-Aortic Balloon pump has just been cleared by the US FDA. The device is indicated to treat severe arrhythmia patients with heart rates as high as 200 beats per minute.

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200 heart beats per minute is the maximum threshold for which Teleflex's Arrow AC3 Optimus Intra-Aortic Balloon Pump, cleared by the US FDA on May 2, is approved to treat severe arrhythmia patients. IABP therapy helps a weakened heart pump blood. The AC3 Optimus is designed for simplified delivery; a physician inserts an intra-aortic balloon catheter into an artery, and using X-ray or imaging, advances the catheter into the aorta. An IABP console, connected to the catheter, controls the inflation and deflation of the balloon. The system incorporates proprietary algorithms to optimize the functions of balloon pump to deliver therapy to challenging patients.

 

Meddevicetracker subscribers can access a full analysis of Teleflex's product portfolio, including the clinical and regulatory status of the AC3 Optimus Intra-Aortic Balloon Pump, here

 

*Source Meddevicetracker  05/05/2017

 
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Medtronic's Resolute Onyx drug-eluting stent is now the first drug-eluting stent in the US available in 4.5 mm and 5 mm sizes, expanding treatment options for patients with extra large vessels.

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4.5 mm and 5 mm are the new sizes available in the US for Medtronic's Resolute Onyx drug-eluting stent. It is the first drug-eluting stent in the US available in these sizes.

The Resolute Onyx DES is designed with the transradial (through the wrist) approach in mind, including 5-Fr catheter compatibility, with stent sizes up to 5.0 mm. The new sizes help expand drug-eluting stent treatment options for patients with extra-large vessels.

Meddevicetracker subscribers can access a full analysis of Medtronic's product portfolio, including the clinical and regulatory status of the Resolute Onyx. If you are not a subscriber.

 

*Source Meddevicetracker  05/05/2017

 
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2,622 devices globally are affected by Medtronic's Class III recall of the StrataMR adjustable valves and shunts, used in treating hydrocephalus.

 

number to know 2662 

Medtronic's global recall of its StrataMR adjustable valves and shunts affects 2,622 devices, the company believes. The devices are used to treat hydrocephalus, a condition that results in abnormal accumulation of cerebrospinal fluid in the brain. They are designed to provide continuous cerebrospinal fluid flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. However, according to the company, a flaw in the device could mean underdrainage that could be fatal. Medtronic had issued a voluntary recall of unused devices in February, but the US FDA on April 19 categorized the action as a Class III recall.

To read Medtech Insight's story on this recall, click here

 

*Source Meddevicetracker 24/04/2017

 
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US FDA is conducting an online survey on its device center's customer service levels, and so far, 88% of respondents have expressed satisfaction.

 

number to know 88

88% of respondents to US FDA's customer service survey expressed satisfaction with the agency's device center, as of April 18, while the remaining 12% were dissatisfied. Manufacturers that have worked with the Center for Devices and Radiological Health on getting products to the US market can take the survey on SurveyMonkey.com and stakeholders can view the results in real-time on that webpage. The survey began on Jan. 1 and is set to conclude June 30.

 

To read Medtech Insight's story on this survey, click here.

 

*Source Meddevicetracker 21/04/2017

 
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The professional diagnostics market is growing at an average rate of 5% a year and this will continue over the next few years, predicts Roche Diagnostics' head of centralized and point of care solutions.

 

5

 

5% is the average rate of growth of the professional diagnostics market, according to Jean-Claude Gottraux, Roche Diagnostics' head of centralized and point of care solutions. Roche Diagnostics has held on to its IVD market leading position for at least the last decade, with its professional diagnostics business leading the charge. Gottraux predicts that the overall IVD market will double over the next 10 years, driven by an aging population and an increase in non-communicable and chronic diseases in both mature and emerging markets.

To read Medtech Insight's interview on IVD trends with Jean-Claude Gottraux and with Jean-Jacques Palombo, lifecycle leader for Roche Diagnostics' cardiac, women's health and personalized health care solutions immunoassay portfolio, click here.

 

*Source Meddevicetracker 10/04/2017

 
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Mirowski Family Ventures will pay $6m to Medtronic to settle attorney’s fees after a patent trial.

 

600000 

 

$6m is the amount of money Mirowski Family Ventures (MFV) have been ordered to pay Medtronic to settle attorney's fees for a trial involving implantable cardioverter defibrillator (ICD) patents. The patents, owned by MFV and licensed to Boston Scientific, have provoked multiple lawsuits over the last few decades. In 2014, the Federal Circuit Court of Appeals ruled that one such patent was invalid and Medtronic would not need to pay any proposed infringement penalty. The court ruling also made the defendants responsible for Medtronic’s $6m attorney fees.

For more information on this development, see Medtech Insight's article here.

 

*Source Meddevicetracker 09/04/2017

 
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€5m in milestone payment is coming Vectura's way, after the company helped Bayer develop and launch a new nebuilizer, Breelib, for delivering the pulmonary arterial hypertension drug Ventavis (iloprost).

 

5000000 

 

Drug delivery device and formulation specialist Vectura Group will receive €5m from its partner, Bayer AG, as a milestone payment following the launch of Breelib, a new smart nebulizer based on Vectura's FOX inhalation system. Breelib delivers Ventavis (iloprost), the drug for treating severe pulmonary arterial hypertension; in a clinical trial that compared Breelib with a currently recommended nebulizer, the new device demonstrated its ability to reduce the mean inhalation time of each inhalation from approximately 11 minutes to approximately 3 minutes, providing for a significant reduction in the overall daily treatment duration for patients. Breelib was CE-marked December 2016 and its application to deliver Ventavis was approved by the European Medicines Agency in October that year. Vectura announced the launch of the device in Poland and the triggering of the €5m milestone payment on April 5.

Meddevicetracker subscribers can access a full analysis of Vectura's product portfolio including the clinical and regulatory status of the FOX inhalation system here.

 

*Source Meddevicetracker 07/04/2017

 
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 Labs in the US have two additional months to report their private-payer pricing data to the Centers for Medicare and Medicaid Services.

 

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Two months is the additional time which the US Centers for Medicare and Medicaid Services have given laboratories to report their private-payer pricing data to the agency, as required under the Protecting Access to Medicare Act. Labs have until May 30 to give details about payment rates from private insurers and test volumes to support a transition to market-based Medicare reimbursement for lab tests.

For more information about this extension and PAMA, read Medtech Insight's article here.

 

*Source Meddevicetracker 04/04/2017

 
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 Boston Scientific's EnduraLife battery can power the company's cardiac resynchronization therapy devices for up to 14.7 years, the longest life of any CRT-D battery.

 

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Boston Scientific's cardiac resynchronization therapy devices that are powered by the EnduraLife battery technology can last up to 14.7 years, the longest time of any CRT-Ds available. The UK's National Institute for Health and Care Excellence (NICE) last month issued medical technology guidance recommending the use of EnduraLife-powered CRT-Ds for treating patients with heart failure. In their evaluation, NICE – which provides evidenced-based guidance to improve health and social care in the National Health Service – concluded that the extended battery life observed with EnduraLife-powered CRT-Ds is likely to reduce the number of avoidable replacement procedures a patient may have to undergo, thereby offering improved outcomes for patients and potential savings to the NHS in England of approximately £6m in the first five years. Boston Scientific's CRT-Ds that incorporate Endura include RESONATE, MOMENTUM, CHARISMA, VIGILANT, AUTOGEN, DYNAGEN, INOGEN, ORIGEN, INCEPTA, ENERGEN, PUNCTUA, and COGNIS CRT-Ds.

To read Medtech Insight's coverage of the NICE recommendation, click here.

Meddevicetracker subscribers can access a full analysis of Boston Scientific's product portfolio, including the clinical and regulatory status of the Resonate CRT-D, here.

 

*Source Meddevicetracker 03/04/2017

 
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In a move to boost its standing in the transcatheter heart valve repair space, Boston Scientific has laid down $435m in cash to buy Swiss company Symetis.

 

number-to-know

 

$435m is what Boston Scientific has agreed to pay – upfront, all-cash – for Symetis, a Swiss rival in the transcatheter aortic valve repair space. While the US multinational said that the deal was to further strengthen its position in the $4bn-plus TAVR market, many questioned Boston Scientific's true rationale behind the move, taking into account that the company ran into trouble with its own Lotus TAVR platform recently.

For more information on the deal and get insight into Boston Scientific's reasoning for this acquisition, read the Medtech Insight article here.

 

*Source Meddevicetracker 31/03/2017

 
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Up to 2,000 patients will be enrolled in Cardiovascular Systems' US pivotal study of its artherectomy system.

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2,000 is the number of patients Cardiovascular Systems plans to enroll in its ECLIPSE Coronary Clinical Trial utilizing the Diamondback 360 Coronary Orbital Artherectomy System (OAS). The ECLIPSE study recently enrolled its first subject at St. Francis Hospital in Roslyn, New York. Half the participants will receive orbital atherectomy prior to DES implantation, while the other half will receive conventional angioplasty, including specialty balloons, followed by DES implantation. The trial is powered to demonstrate differences in the primary endpoints of post-procedural minimal cross-sectional area (assessed by intravascular imaging in a subset of up to 400 patients) as well as in the clinical outcome of target vessel failure at one year. ECLIPSE will also evaluate key health economic outcomes.

Meddevicetracker subscribers can access a full analysis of Cardiovascular System's product portfolio including the clinical and regulatory status of the Diamondback 360 Coronary Orbital Artherectomy System here.

*Source Meddevicetracker 31/03/2017

 
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 There were 57 quality-related warning letters sent by US FDA to device-makers in 2016. That's the fewest since 2002.

 

number to know - 57

 

57 is the number of quality-related warning letters issued by FDA to device manufacturers in 2016. That is a 14-year-low that has left agency officials scratching their head as to why so few were sent to firms. There is no one factor to attribute the drop to, the agency told Medtech Insight in our exclusive report on FDA warning letter trends. (Also see "Warning Letter Nosedive: US FDA Writes Fewest Quality-Related Missives Since 2002; Agency Isn't Sure Why" - Medtech Insight, 28 Mar, 2017.)

 

*Source Meddevicetracker 30/03/2017

 
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DexCom's G5 Mobile continuous glucose monitor remains the only product to qualify for Medicare reimbursement as a therapeutic CGM.

 

number to know - 1

 

1 is the number of therapeutic continuous glucose monitor's currently covered under the current US Center for Medicare & Medicaid Services criteria for all people with diabetes on intensive health therapy. The DexCom G5 Mobile system is the only device that falls under CMS's current criteria. In order to be included in this category, the system must be defined as therapeutic CGM, meaning you can make treatment decisions using the device. Dexcom Inc.'s G5 Mobile is the only system approved by the FDA to meet that criteria. (Also see "Dexcom First To CGM Reimbursement Finish Line" - Medtech Insight, 17 Jan, 2017.)

Meddevicetracker subscribers can access a full analysis of DexCom's product portfolio including the clinical and regulatory status of the G5 Mobile CGM. Not a subscriber? Click here to request your free demo.

 

*Source Meddevicetracker 29/03/2017

 
Not a subscriber, click here to request your free demo.

 


 

There are 280 days until collection of the medical device tax is scheduled to restart in the US after a two-year moratorium. Medtech lobby groups will spend that time seeking a permanent repeal of the tax, but one opportunity was lost March 24 when Congress retreated on plans to "repeal and replace" the Affordable Care Act.

 

 

 

280 is the number of days left until the US government is scheduled to restart collection of the 2.3% excise tax on qualifying sales of medical devices. Medtech groups had hoped to expunge this particular countdown with permanent repeal of the tax, included in House Republican legislation to "repeal and replace" the Affordable Care Act (Obamacare). But that package, the American Health Care Act, has now been stopped in its tracks, as Medtech Insight wrote March 24, and the device sector must find another legislative pathway to achieve its goal. (Also see "Device-Tax Repeal Opportunity Slips Away As GOP Pulls Health Bill From Consideration" - Medtech Insight, 24 Mar, 2017.)

Interested in keeping up on what the US Congress is doing to impact medtech? Click here to set up a custom alert.

 

*Source Meddevicetracker 28/03/2017

 
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Medtronic's newly-cleared insertable cardiac monitor, which is a third of the size of an AAA battery, has demonstrated its ability to reduce false brachycardia detection by 95%.

 

 

 

95 is the percentage reduction in false bradycardia (slow heartbeat) detection that Medtronic's Reveal LINQ insertable cardiac monitor is able to achieve. Medtronic announced Mar. 13 that it has received FDA 510(k) clearance to market in the US the Reveal LINQ for detecting abnormal heartbeats. Reveal LINQ ICM with TruRhythm Detection that allows physicians to continuously and wirelessly monitor a patient's heartbeat for up to three years, is approximately one-third the size of an AAA battery (~1 cc). It is placed just beneath the skin through a small incision of less than 1cm in the upper left side of the chest, using a minimally invasive procedure, and its presence is often nearly undetectable to the naked eye once the incision has healed. The device communicates wirelessly with a patient bedside monitor that uploads device data to the Medtronic CareLink network; it is MR-Conditional, allowing patients to undergo magnetic resonance imaging, if needed.

 

Meddevicetracker subscribers can access a full analysis of Medtronic's product portfolio, including the clinical and regulatory status of the Reveal LINQ ICM, here.

 

*Source Meddevicetracker 24/03/170

 


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In a pivotal study that pits Abbott's fully bioabsorbable vascular scaffold Absorb against its drug-eluting stent Xience, the company found that the two-year rate of target lesion failure in Absorb was 11%, significantly higher than that found in Xience.

 

number to know

 

11% is the cumulative two-year target lesion failure rate demonstrated by Abbott's Absorb bioabsorbable vascular scaffold in the ABSORB-III pivotal trial. This is significantly higher (p=0.03) than the 7.9% two-year TLF rate found in Xience, the drug-eluting stent which Absorb is being evaluated against in the trial. Further data showed that this higher TLF rate for Absorb was seen when the device was implanted in small vessels. However, when implanted in appropriately-sized vessels, the difference was smaller and not statistically significant at 9.4% for Absorb vs 7% for Xience (p=0.11). The data was presented at the 2017 meeting of the American College of Cardiology, held in Washington DC, on Mar. 17-19.

Meddevicetracker subscribers can access a full analysis of Abbott's product portfolio, including the clinical and regulatory status of the Absorb BVS, here.

 

*Source Meddevicetracker 23/03/170

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Only three leadless pacemakers have been CE marked o date, as revealed following the publication of recent UK guidelines on how to evaluate such products.

 

number to know

 

There are only three leadless cardiac pacemakers that have received a CE-mark to date, according to a recent guideline issued by the UK Medicines and Healthcare products Regulatory Agency on the clinical evaluation of such products. At the time of writing the March 2017 guideline, the MHRA said CE-marks had been awarded to St. Jude Medical Inc. ’s Nanostim and Medtronic PLC ’s Micra – both of which are intracardiac, entirely self-contained rate-responsive ventricular demand (VVIR) pacemakers. Also, CE-mark had been granted to EBR Systems Inc. ’ WICS, which effectively adds CRT (cardiac resynchronization therapy) capability to an existing transvenous Implanted pacemaker/implantable cardioverter defibrillator. Other leadless pacing systems are in development and it is thought that this modality may one day provide a wider range of therapies, including multisite endo- or epicardial pacing for CRT plus antitachycardia pacing in combination with non-transvenous ICDs.

 

To gain more insight on MHRA’s guideline on this topic, read Medtech Insight’s article here

 

 *Source Meddevicetracker 22/03/170

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Medtronic's transcatheter aortic valve replacement systems, CoreValve and CoreValve Evolut R, have demonstrated a 12.6% rate of all-cause mortality or disabling stroke, at two years. This data from the SURTAVI study were presented at ACC 2017.

 

126

 

12.6% is the rate of all-cause mortality or disabling stroke at two years that Medtronic PLC's CoreValve and CoreValve Evolut R system showed in the SURTAVI study. The top-line results were presented at the 2017 American College of Cardiology, held in Washington, DC, between Mar 17-19. The study compares transcatheter aortic valve replacement (TAVR) using the self-expanding CoreValve or EVOLUT R system with surgical aortic valve replacement (SAVR) for the treatment of severe symptomatic aortic stenosis in patients deemed intermediate surgical risk by Heart Team assessment. SAVR had a 14% rate of all-cause mortality or disabling stroke at two years. The minimally-invasive TAVR procedure also demonstrated significantly better mean aortic valve gradient (7.8 mm Hg vs. 11.8 mm Hg; p<0.001) at two years, while neither TAVR- nor SAVR-treated patients displayed evidence of structural valve deterioration at two years.

 

Meddevicetracker subscribers can access a full analysis of Medtronic's product portfolio including the clinical and regulatory status of the CoreValve System here and CoreValve Evolut R here.

 

 *Source Meddevicetracker 2/03/170

Not a subscriber, click here to request your free demo.

 

 


 

 ResApp is seeking to recruit 1,111 pediatric patients for its clinical study of the ResAppDx for the diagnosis of respiratory disease.

 

Daily number to know

 

1,111 is the number of patients that ResApp expects to enroll in its SMARTCOUGH-C multi-site, double-blind, prospective clinical study to investigate ResAppDx for the diagnosis of respiratory disease in infants and children using cough sounds. The company recently announced that enrollment in the study is progressing well; it aims to enroll patients aged 29 days to 12 years. The coprimary endpoints of the study are the diagnosis of pneumonia compared to clinical and radiologic diagnosis. Secondary endpoints are diagnosis of upper respiratory tract infection, lower respiratory involvement, croup, asthma/reactive airways disease, and bronchiolitis compared with a clinical diagnosis.


Meddevicetracker subscribers can access a full analysis of ResApp's product portfolio, including the clinical and regulatory status of the ResAppDx, here.

 

*Source Meddevicetracker 17/03/17

Not a subscriber, click here to request your free demo.

 


 

Sales of foam wound dressings, which account for the largest segment in the advanced wound dressing market, are expected to grow 15% to exceed $2bn by 2020.

 

number to know

 

15% is the expected growth rate for foam wound dressing sales in the five-year period between 2015 and 2020. This segment, the largest in the advanced wound dressing market, recorded sales of $997.3m in 2015 and this is anticipated to exceed $2bn by 2020. Smith & Nephew had been the long-time leader of foam wound dressings but in 2015, was pipped to the post by Mölnlycke.

To read Meddevicetracker's Advanced Wound Care Products Market report, click here.

Top-line findings from the report, published by Medtech Insight, can be found here.

 

*Source Meddevicetracker 16/03/17

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Five years ago, BoneSupport signed on Biomet – now Zimmer Biomet – as the exclusive US distributor of its Cerament bone substitute product. The two companies have decided to renew and extend the partnership.

 

number to know

Swedish specialist in injectable bone substitute materials BoneSupport ABsucceeded in getting big ortho player Biomet on board, five years ago in 2012, as its US distribution partner for its Cerament bone void filler. On Mar. 14, the companies – Biomet now having merged with Zimmer – announced they will be extending this partnership. Cerament is approved for orthopedic, trauma and foot and ankle indications. BoneSupport also has Cerament G, a bone void filler that elutes the antibiotic gentamicin, and Cerament V, which elutes vancomycin, which are CE marked but not yet approved in the US.

 

Meddevicetracker subscribers can find out more about BoneSupport and its pipeline of products here.

 

*Source Meddevicetracker 15/03/17

Not a subscriber, click here to request your free demo.

 

 

 

 


 

 

Turkey's nationwide City Hospitals initiative will add 41,000 new hospital beds to its health-care system, offering medtech suppliers a new opportunity for revenue growth.

 

number to know

 

41,000 is the number of new hospital beds that Turkey's City Hospitals project will add to the health-care infrastructure. The initiative will see 29 new hospitals built across the country and offers a substantial opportunity for medtech companies to supply their products and services. Siemens Healthineers in February won a major tender to provide clinical lab services for two of these new city hospitals; based on the anticipated volume of tests that these hospitals will run, the deal could generate revenue of over €100m a year.

 

To find out more about Turkey's City Hospitals project and how Siemens Healthineers is capitalizing on this initiative, read Medtech Insight's interview with Sevket On, the company's general manager in Turkey, here.

 

 

*Source Meddevicetracker 14/03/17

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The EchoPulse system, from French company Theraclion, has demonstrated it can achieve a 68.3% median volume reduction in benign thyroid nodules in patients, a six months.

 

 

 

68.3% is the median volume reduction, at six months, in the size of large benign thyroid nodules in patients treated with Theraclion's EchoPulse echotherapy device. The data, published on Mar. 2 in the journal Thyroid, came from an Asian, open-label, 73-patient study, designed to evaluate the efficacy of a single treatment of ultrasound-guided HIFU ablation, using EchoPulse to treat small to large-sized benign thyroid nodules. The device combines high-intensity focused ultrasound for therapy and real-time ultrasound imaging for monitoring. This double function allows a precise, individualized, noninvasive and outpatient treatment of solid tumors such as breast fibroadenomas and benign thyroid nodules. EchoPulse is CE marked; in January, Theraclion, based in Malakoff, France, initiated a US pivotal trial and anticipates enrolling 100 patients.

Meddevicetracker subscribers can access a full analysis of Theraclion's product portfolio including the clinical and regulatory status of the EchoPulse Echotherapy Device, here.

 

*Source Meddevicetracker 10/03/17

Not a subscriber, click here to request your free demo.

 

 

 


 

 

232 patients is the anticipated enrollment target for Intact Vascular's IDE study evaluating its Tack Endovascular System for treating critical limb ischemia.

 

Number to Know 232 

 

232 is the number of patients that Intact Vascular plans to enroll in its US IDE study, TOBA II BTK, initiated in February This is a prospective, multi-center, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard balloon angioplasty in the popliteal and tibial arteries for the treatment of critical limb ischemia (CLI). Tack is designed to repair dissections (or tears) in the artery wall that frequently occur as a complication of balloon angioplasty. The system allows physicians to repair these dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options.

 

TOBA II BTK is the first known industry-sponsored pivotal clinical trial approved by the U.S. Food and Drug Administration to investigate a permanent vascular implant in arteries below the knee, according to Intact Vascular.

 

Meddevicetracker subscribers can access a full analysis of Intact Vascular's product portfolio, including the clincal and regulatory status of the Tack Endovascular System, here.

 

*Source Meddevicetracker 09/03/17

Not a subscriber, click here to request your free demo.

 

 


 

There are zero female CEOs among the top 20 medtech companies listed on Medtech Insight's MTI 100 league table. The significantly smaller proportion of women executive leaders, compared to their male counterparts, is pervasive in the life sciences industry.

 

number to know 

With Mar. 8 marking International Women's Day, Medtech Insight did a tally of how many female CEOs there were among the top 20 medtech companies in the MTI100 league table. There were no women at the head of these multinational groups. Gender diversity, or the lack of, is a pervasive issue in the life sciences industry. On Jan. 11, in an open letter to the biopharma community, more than 100 life science leaders outlined guiding principles and best practices to improve gender diversity throughout the industry.


To see if there are any female CEOs among the other MTI100 companies, click here to see the full league table.

 

*Source Meddevicetracker 08/03/17

Not a subscriber, click here to request your free demo.

 

 


 

A total of 37,724 women have filed suit against Johnson & Johnson-subsidiary Ethicon Endo-Surgery in ongoing multi-district litigation being heard in the Southern District of West Virginia. The women say they were injured by the company’s pelvic mesh products.

 

number to know

 

Ethicon Endo-Surgery is facing a class action involving 37, 724 women, as of Mar. 6, who are suing the Johnson & Johnson-subsidiary for complications they suffered after being implanted with the company’s pelvic mesh. These women received the mesh implants to treat urinary incontinence or pelvic organ prolapse and have reported complications including pain and the need for revision surgeries. The US FDA and manufacturers of these products had acknowledged safety concerns with these products back in 2012. Other pelvic mesh makers embroiled in these suits include Covidien Ltd., Boston Scientific Corp. and Cook Medical Inc.; the companies have settled some complaints, but many more remain open.

To find out how high the jury awards in these mesh cases have been to date, read Medtech Insight’s latest story on this subject here.

 

*Source Meddevicetracker 07/03/17

Not a subscriber, click here to request your free demo.

 

 


 

Israel boasts 18 hi-tech incubators, designed to nurture start-ups and maintain the country’s well-recognized position as a medtech innovation generator.

 

number to know

The Israeli government's hi-tech incubator program, one of the key sources of funding for the country’s start-ups, was founded in 1991 and today there are 18 incubators in total, all of which have been privatized. The incubators function as a center for entrepreneurship and nurture companies from seed to early stage, thereby minimizing the risk to future investors. They also offer a supportive framework for the establishment of a company and development of a concept into a commercial product, with many companies’ R&D facilities based at the incubator.
To gain more insight into Israel’s incubators, the venture funding landscape, where the players see the opportunities are for Israeli innovation, read Medtech Insight’s article here.

 

*Source Meddevicetracker 06/03/17

Not a subscriber, click here to request your free demo.

 


 

2,000,000 is the number of neurons lost per minute in a patient who has suffered a major acute stroke and is not receiving reperfusion. These patients could potentially benefit from treatment with Medtronic's Solitaire stent retriever, which has received a further boost from positive data recorded in the STRATIS registry.

 

Number to Know 200000

 

A patient who has suffered a major acute stroke and is not receiving reperfusion loses 2,000,000 neurons per minute. Medtronic PLC's Solitaire stent retriever for performing mechanical thrombectomy have demonstrated clinical benefits when used by community hospitals on acute stroke patients. Data from the STRATIS registry, presented at the International Stroke Conference on Feb. 28, indicate that Solitaire can be used equally as well in community hospitals as stroke centers. It also found that the benefits of transferring these patients to specialized centers is outweighed by the potential for additional brain damage that can result from the extra time it takes to get there.

*Source Meddevicetracker 03/03/17

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36 is the number of patients Swedish company SpectraCure AB is expecting to enroll in the study of its photodynamic therapy for recurrent prostate cancer.

 

Number to Know 36

 

 

SpectraCure AB is seeking to enroll 36 patients for its Phase I clinical study to assess the clinical effectiveness of the SpectraCure P18 photodynamic therapy system in treating recurrent prostate cancer. The system incorporates interstitial multiple diode lasers controlled via SpectraCure’s proprietary IDOSE dose control software to activate the injected photosensitizer verteporfin. The trial is expected to be completed by the end of August 2019.

Meddevicetracker subscribers can find out more about the Swedish company and details of the clinical trial here.

 

*Source Meddevicetracker 02/03/17

 Not a subscriber, click here to request your free demo.

 


 

There are at least 30 US states with statutes that can protect cybersecurity whistleblowers.

 

number to know

 

In the US, there are more than 30 states with statutes on the books that can offer protection to cybersecurity whistleblowers in privately owned companies, including medical device firms. This is significant in light of the medtech industry moving increasingly into a world of connected products, and where cybersecurity issues with devices have arisen and are likely to persist. Whistleblowers of publicly traded companies can capitalize on a rewards program offered by the US Securities and Exchange.


To find out what incentives and initiatives are in place for individuals to raise the alarm on medtech companies falling foul of cybersecurity laws.

 

*Source Meddevicetracker 01/03/17

 

Not a subscriber, click here to request your free demo.

 

 

 


 

 0.03mm is the width of the robotically controlled surgical needle used in a groundbreaking procedure to remove a blood clot in the eye.

 

number to know

 

 Innovators in surgical robotics are striving to develop devices with ever decreasing dimensions to allow use in the tiniest spaces within the body. In January, Peter Stalmans at Belgium’s University Hospitals Leuven used a surgical robot with a needle of barely 0.03mm wide to slowly inject a thrombolytic drug in the retinal vein of a patient to dissolve a blood clot (causing retinal vein occlusion) – the first procedure of its kind. Until now, it would have been impossible to safely insert a needle into the vein by hand to inject medicine and remove the blood clot.


To find out more about this and other technological advances in surgical robotics, including robotic catheters for atrial fibrillation treatment and origami robots.

 

*Source Meddevicetracker 28/02/17

 

Not a subscriber, click here to request your free demo.

 


 

 

PathoQuest’s NGS-based diagnostic test for infectious disease can identify 3 times more pathogens than conventional tests.

 

number to know

 

PathoQuest’s iDETECT Dx blood test for infectious disease can identify 3 times more relevant pathogens in a sample as compared to conventional tests in a recent study published in the journal Clinical Microbiology and Infection. iDETECT utilizes next-generation sequencing-based metagenomic methods to identify bacteria and viruses in blood samples from patients. It differs from conventional testing methodologies because it does not require a lab to “grow” the microorganisms, and does not require microbiologists and clinicians to preselect which bacteria or viruses they want to test for. iDETECT can identify DNA and RNA sequences from bacteria and viruses present in only small quantities in blood samples and also utilizes a non-targeted approach to the identification of pathogens.

 

*Source Meddevicetracker 27/02/17

 

Meddevicetracker subscribers can access more details here of the PATHOQUEST-1 study comparing iDETECT with conventional diagnostic methods.

Not a subscriber, click here to request your free demo.

 

 

 


 

Infusion pumps, used in abundance in hospitals but prone to error, caused 710 patients deaths between 2005-2009.

 

Number to Know 710

 

710 is the number of patient deaths resulting from the 56,000 adverse infusion pump events recorded by the US FDA between 2005-2009. During this time frame, 87 pumps were recalled. Additionally, a 2007 report from the Institute of Medicine stated that dealing with patient safety issues resulting from infusion pumps costs the health system $2bn annually. One of the keys to addressing this problem lies in improving the devices’ interoperability with hospital IT systems.

 

*Source Meddevicetracker 24/02/17

 

Meddevicetracker subscribers can access a full analysis of Lombard Medical and its product portfolio here.

Not a subscriber, click here to request your free demo.

 


 

Number to Know 15

 

Lombard Medical has seen 15 Japanese patients treated with its Aorfix endovascular stent graft using the latest-generation IntelliFlex LP system, which was approved in Japan a month ago and launched commercially a week ago.

 

Fifteen is the number of patients in Japan who have been treated with Lombard Medical's Aorfix endovascular stent graft using the next-generation IntelliFlex LP (low-profile delivery system) in the first week after the latter was launched on Feb.1.

 

Aorfix is designed to treat infra-renal aortic and aorto-iliac aneurysms, and the new IntelliFlex LP gained Japanese regulatory approval in January. The delivery system features a low-profile replacement to the current platform, as well as several design improvements to allow better control of pop-in deployment. Medico’s Hirata, which specializes in commercializing vascular products, is the exclusive distributor of Aorfix with IntelliFlex LP in Japan. Lombard also recently signed on another Asian partner, MicroPort Scientific; MicroPort has gained exclusive distribution rights for Aorfix and Altura for China and Brazil.

 

*Source Meddevicetracker 13/02/17

 

Meddevicetracker subscribers can access a full analysis of Lombard Medical and its product portfolio here.

Not a subscriber, click here to request your free demo.

 

 


 

Number to Know 800000

 

Medtronic will be targeting the 800,000 Canadians affected by peripheral arterial disease, after gaining Canadian approval for its IN.PACT Admiral drug-coated balloon.

 

800,000 is the number of people in Canada affected by peripheral arterial disease and the potential market that Medtronic is targeting with its IN.PACT Admiral drug-coated balloon, which received Health Canada approval on Feb 9. and has launched the IN.PACT DCB in Canada. IN.PACT is used in patients with PAD in the upper leg, specifically, in the thigh (superficial femoral arteries) and behind the knee (popliteal arteries). The procedure involves inserting a compressed balloon into the artery and inflating the balloon to re-open the blockage. when the balloon is inflated, the coating - composed of paclitaxel and urea - comes into contact with water in the bloodstream. This hydrates the urea, facilitating the release of solid-phase paclitaxel to the vessel wall to help prevent restenosis. IN.PACT is CE marked and US FDA-approved.

 

*Source Meddevicetracker 10/02/17

Meddevicetracker subscribers can access a full analysis of the clinical and regulatory status of IN.PACT Admiral and a profile of Medtronic.

Not a subscriber, click here to request your free demo.

 

 


 

Number to Know 30

 

30% is the proportion of patients in the US each year who get assessed for potentially cancerous thyroid nodules but their test results are inconclusive. Veracyte's Afima test is positioned to address this issue.

 

30 is the percentage of patients who are evaluated for potentially cancerous thyroid nodules in the US each year, and receive an indeterminate result. These patients then undergo surgery, but 80% of these cases prove to be benign, meaning the surgery was unnecessary. Veracyte's Afirma is a laboratory-developed test to determine if thyroid nodules are cancerous through fine needle aspiration (FNA) biopsies and the company this month scored a major deal with Quest Diagnostics which will see Afirma being offered to Quest customers as of the second quarter of 2017.

 

*Source Meddevicetracker 09/02/17

 

Meddevicetracker subscribers can access a profile of Veracyte, including data on Afirma and its other tests Envisia and Percepta, here.

Not a subscriber, click here to request your free demo.

 

 


 

Number to Know 76000000

 

 $76m is the size of regenerative medicine specialist MiMedx's share purchase reprogram, which has just been expanded after its board decided it was "a favorable investment" for the company.

 

$76m is the size of MiMedx's share repurchase program after its board of directors this month authorized for the amount to be expanded by an additional $10m. MiMedx specializes in regenerative biomaterials and bioimplants processed from human amniotic membrane. It has a number of products cleared for marketing by the US FDA, including EpiFix, which is cleared for treating diabetic foot ulcers and chronic venous ulcers and in preclinical trial to assess its use in cardiovascular disease. It also has in development other products for orthopedic and cardiovascular indications. MiMedx said that in light of the prevailing market conditions, the company's available resources and other factors, the board believes the stock repurchases are a favorable investment for the company.

 

*Source Meddevicetracker 08/02/17


Meddevicetracker subscribers can access a profile of MiMedx, including data on its product portfolio, here.

Not a subscriber, click here to request your free demo

 

 


 

5000000 | Medtech Insight

 

$5m is how much Novo Nordisk has invested in bionic pancreas developer, Beta Bionics.

 

$5m is the amount of cash Novo Nordisk has pumped into Beta Bionics as part of a strategic partnership between the two companies to develop a bionic pancreas that will be compatible with the drug maker’s NovoLog insulins. Beta’s iLet bionic pancreas is designed for automated delivery of insulin alone and insulin and glucagon, and incorporates Dexcom’s continuous glucose monitoring technology and smart algorithm). Beta last year also received a $5m investment from another major insulin drug maker, Eli Lilly.

 

*Source Meddevicetracker 07/02/17

 

Meddevicetracker subscribers – click here to get a profile of Beta Bionics and data on iLet.

Not a subscriber? Click here to request your free demo today.

 

 


 


 

 
 

 

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