August 28, 2017
Tandem Diabetes Care Announces FDA Approval and Launch of t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM Integration
Tandem Diabetes Care announced U.S. Food and Drug Administration (FDA) approval and commercial launch of the t:slim X2 Insulin Pump with Dexcom G5 Mobile continuous glucose monitoring (CGM) integration, the first sensor-augmented insulin pump approved to let users make treatment decisions without pricking their finger. The software featured on this pump will also be available to current t:slim X2 Pump users at no cost via remote software update, allowing them to add CGM integration to their existing pumps from home using a personal computer. Individual emails are being sent directly to t:slim X2 Pump customers with instructions on how to perform the update. The t:slim X2 Pump with Dexcom G5 Mobile CGM integration is approved for ages 6 and older.
This approval marks the Company’s fifth new insulin pump launch in only 5 years and the second featuring Dexcom technology. It is the only available pump that conveniently displays a user’s insulin delivery activity and Dexcom G5 Mobile CGM data together on a single device. The t:slim X2 Pump is also the only insulin pump capable of remote software updates2, allowing existing users to add features like CGM integration from home. It is up to 38% smaller than other pumps, but includes advanced features like a large color touchscreen, Bluetooth radio, rechargeable battery, USB connectivity, 300-unit insulin capacity and watertight construction (IPX7).
The t:slim X2 Pump can operate as a stand-alone insulin pump without CGM, or be paired with the Dexcom G5 Mobile CGM to track glucose continuously and display that information directly on the pump’s home screen. Dexcom G5 Mobile is the only CGM system FDA approved to let users make treatment decisions without pricking their finger. Dexcom is also consistently rated the #1 CGM brand in independent patient surveys. In addition to integration with the t:slim X2 Pump, dynamic glucose data from the Dexcom G5 Mobile CGM can be easily accessed and shared using a compatible mobile device.
See more about the t:slim X2 Insulin Pump on Meddevicetracker.
C.R. Bard Receives FDA Premarket Approval of the LUTONIX 035 Drug Coated Balloon
C. R. Bard announced the LUTONIX 035 Drug Coated Balloon PTA Catheter (DCB) has been granted premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) for a new indication and is now available for sale in the United States. With this approval, the LUTONIX 035 DCB Catheter becomes the first and only drug coated balloon that is FDA approved as safe and effective in end stage renal disease (ESRD) patients with stenotic lesions in dialysis arteriovenous (AV) fistulae.
This latest approval adds to the prior FDA indication of the LUTONIX 035 DCB Catheter for the treatment of superficial femoral artery (SFA) and popliteal artery disease.
The FDA approval was based on the results of the LUTONIX AV Clinical Trial, the first investigational device exemption (IDE) trial using drug coated balloons in patients with stenotic lesions in AV fistulae. The follow-up results from randomized patients who were treated with the LUTONIX 035 DCB Catheter demonstrated safety comparable to uncoated balloons.
The LUTONIX 035 DCB Catheter also demonstrated a sustained clinical benefit compared to conventional angioplasty through 12 months:
- 71.4% target lesion primary patency (TLPP) at 180 days with superior results at 210 days (DCB 64.1% vs. PTA 52.5%)
- 31.3% fewer reinterventions compared to PTA at 6 months
- Nearly two (2) months more reintervention-free days (217 days vs. 163 days) compared to PTA
- 31.2% improvement in TLPP through 12 months
- 95% freedom from primary safety event, indicating a consistent safety profile to PTA
See more about the LUTONIX 035 Drug Coated Balloon on Meddevicetracker.
Medtronic Announces Interim Results from SPYRAL HTN-OFF MED Study
Medtronic announced its intent to move forward with a new renal denervation pivotal trial following positive first results from a sham-controlled study in patients with high blood pressure. Investigators of the SPYRAL HTN-OFF MED Study found statistically significant and clinically important blood pressure reductions in the patients treated with renal denervation (RDN) across both office and ambulatory systolic and diastolic measurements. The data in the first 80 patients enrolled in the study at three months were presented in a late-breaking clinical trial session at the European Society of Cardiology (ESC) meeting in Barcelona, Spain and published simultaneously in The Lancet.
The initial three-month data found that patients who underwent renal denervation had their office systolic blood pressure (OSBP) decline an average 10 mm Hg, resulting in a 7.7 mm Hg difference with the patients in the sham control arm (p=0.016), and their diastolic blood pressure declined an average 5.3 mm Hg, resulting in a 4.9 mm Hg difference with the sham control arm (p=0.008). With a systolic blood pressure difference of 7.7 mm Hg between the two groups, a recent meta-analysis published in The Lancet associated that decrease with a relative risk reduction of approximately 20 percent for major cardiovascular events, including heart attack and stroke.
In SPYRAL HTN OFF-MED renal denervation patients, the 24-hour systolic ambulatory blood pressure (ABPM) declined 5.5 mm Hg, resulting in a 5 mm Hg difference from the sham control arm (p=0.041), and the diastolic AMBP declined 4.8 mm Hg, resulting in a 4.4 mm Hg difference from the sham control arm (p=0.002). Additionally, there were no reported cases of new or worsening renal failure, vascular complications, or other major adverse events, confirming the safety of the RDN procedure - even with a revised procedural approach that extended ablations into the kidney's branch arteries and an increase in total number of ablations compared with previous RDN trials.
The SPYRAL HTN-OFF MED Study evaluated RDN in the absence of any antihypertensive medications compared to a sham-controlled population to isolate its effect on blood pressure reduction. The Study enrolled 353 patients who were either drug naïve or willing to discontinue medication for four months, with mild-to-moderate hypertension (OSBP equal to or more than 150 mm Hg and less than 180 mm Hg) at 24 centers in the U.S., Europe, Japan, and Australia. Prior to randomization, patients were required to stop taking their antihypertensive medication during a period of three to four weeks, known as a medication washout. During the washout period and the three months following randomization, patients were monitored to ensure their blood pressure would not exceed 180mm Hg.
Unlike SYMPLICITY HTN-3, where patients self-reported adherence, and change in medications occurred among 40 percent of patients, the SPYRAL HTN-OFF MED Study limited that variability, as patients remained off their medication throughout the duration of the study as confirmed by serum and urine testing for antihypertensive medication. Additionally, the aftermath of SYMPLICITY HTN-3 revealed new anatomical insights showing that renal nerves are easier to access when the catheter treats the renal artery segments located close to the kidney. While SYMPLICITY HTN-3 only averaged five ablations in the main renal artery and no ablations in the branch arteries, the unique, flexible design and low profile of the investigational Symplicity Spyral system achieved an average of 10 main renal artery and 13 branch artery ablations per kidney.
The clinical program utilizes Medtronic's next-generation renal denervation technology, composed of the flexible, 6 Fr guide catheter compatible, Symplicity Spyral multi-electrode renal denervation catheter and Symplicity G3 renal denervation RF (radiofrequency) generator. The Symplicity Spyral system is investigational in the United States and Japan.
See more about the Symplicity Renal Denervation System at Meddevicetracker.
August 29, 2017
Abbott Issues New Updates For Implanted Cardiac Devices
Abbott notified physicians of updates to its implantable pacemakers and defibrillators as part of its ongoing commitment to continuously improve patient care.
The new device updates include a Battery Performance Alert for our implantable cardioverter defibrillators (ICDs) that provides physicians with earlier warning of the potential for the low risk of premature battery depletion. They also include a planned update to pacemaker firmware (a kind of software) to add additional security protections designed to reduce the risk of unauthorized access to patients' pacemakers.
There have been no reports of unauthorized access to any patient's implanted device, and according to an advisory issued by the U.S. Department of Homeland Security, compromising the security of these devices would require a highly complex set of circumstances.
Abbott is communicating with regulatory authorities worldwide to implement the new updates to the implantable devices. Abbott's recommendation, and that of its Cyber Security Medical Advisory Board, is that a patient have a conversation with their physician to determine if the update is right for them. Abbott will continue to make updates and product enhancements across its devices as part of the company's ongoing commitment to provide safe, effective and secure products for patients.
See more about Abbott Laboratories on Meddevicetracker.
CALM-FIM Interim Data Presented for Vascular Dyamics’ MobiusHD to Treat Resistant Hypertension
Vascular Dynamics announced that interim results of the company’s first-in-human trial of its MobiusHD implant were presented in a podium presentation at the European Society of Cardiology's ESC Congress 2017, held August 26–30 in Barcelona, Spain.
The data showed an average reduction of ambulatory systolic blood pressure of 20 mm Hg from baseline in the first 40 patients (of an anticipated 50) to reach the 6-month endpoint in studies conducted in the United States and the European Union.
According to the company, these interim results of the CALM-FIM (Controlling and Lowering Blood Pressure with MobiusHD First-in-Man) trial, provided results from the first cohort of 40 patients evaluated in the United States (CALM-FIM US) and Europe (CALM-FIM EUR). The data demonstrated that at the 6-month evaluation point, 88% of the 40-patient cohort had a > 10-mm Hg drop in office systolic blood pressure or ≥ 5-mm Hg drop in 24-hour ambulatory systolic blood pressure. Many of these patients also experienced a reduction in their use of antihypertensive medication.
Vascular Dynamics stated that the ESC presentation of these interim results will be followed by the publication of the final results of the CALM-FIM EU study in The Lancet on September 1, 2017.
The minimally invasive MobiusHD system is designed to amplify the signals received by the surrounding arterial baroreceptors and thereby increase the body’s natural response to lower blood pressure through vasodilation.
The MobiusHD system has received CE Mark approval for the treatment of hypertension in the European Union. In the United States, the MobiusHD device is limited by law to investigational use only and is not commercially available, advised Vascular Dynamics
See more about the MobiusHD on Meddevicetracker.
August 30, 2017
Repatha Receives Approval for New 420mg Single-Dose Delivery Option in Japan
Amgen Astellas BioPharma and Astellas Pharma announced that Amgen Astellas received a marketing approval of Repatha SC Injection 420 mg Auto mini doser (AMD), an additional dosage formulation of Repatha, a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).
The new Repatha SC Injection 420 mg AMD is a single-use on-body infusor with prefilled cartridge for every-four-week subcutaneous injection. An every-two-week subcutaneous injection option is possible for homozygous familial hypercholesterolemia (FH) patients who are unable to appropriately control their LDL cholesterol level.
Amgen Astellas and Astellas expect to further contribute to the treatment of patients with FH or hypercholesterolemia patients who have high risk in cardiovascular events and do not adequately respond to statins by providing this new AMD option to the already approved Repatha SC Injection 140mg Syringe and Repatha SC Injection 140mg pen.
See more about the Repatha SC Autoinjector on Meddevicetracker.
Abbott Initiates U.S. Pivotal Study of AMPLATZER Device to Correct Common Congenital Heart Defect in Newborns
Abbott announced it has initiated a U.S. pivotal clinical study evaluating the safety and effectiveness of a modified version of its AMPLATZER device designed to correct a common congenital heart defect that occurs in approximately 80,000 pre-term infants in the U.S. each year.
Patent ductus arteriosus, or PDA, is a life-threatening vascular pathway, or duct, in the heart that remains open due to failure of the fetal duct to close after birth. The duct, which serves as a bridge between blood vessels and is located between the main two arteries exiting the heart, is present in normally developing fetuses and typically seals itself after birth. In some cases, primarily in premature babies, the PDA fails to spontaneously close, which can result in serious difficulty breathing and inability to feed -- two critical tasks for newborn babies.
Abbott is developing the AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) device, which is already approved for use in Europe, with the goal of providing physicians with a nonsurgical treatment option for closing the PDA defect in newborns and pre-term infants. The wire mesh device is placed non-surgically through a catheter inserted through the leg and guided through vessels to the heart, where it is placed to seal the duct. The new device is similar to the AMPLATZER Duct Occluder II product, available in larger sizes, and it builds upon more than 15 years of clinical success for AMPLATZER Occluder therapies.
Pharmaceuticals can sometimes be used to promote closure of the duct, but are less effective in pre-term infants. For pre-term infants not responsive to pharmaceuticals, current treatment options are limited to surgery, which is not always possible, or to leave the duct open, which is not optimal for young infants. When the duct remains open, blood is redirected away from the body to the lungs and heart. Left untreated, the condition can lead to serious complications, including heart and kidney failure, damage to the intestines, bleeding in the brain, altered nutrition and growth, and ultimately, becomes a risk factor for chronic lung disease and death.
The study will enroll approximately 50 patients at up to 10 centers across the United States. The first seven patients were enrolled at Le Bonheur Children's Hospital in Memphis, Tenn., and treated by Shyam Sathanandam, M.D., associate professor at the University of Tennessee.
If successful, the U.S. trial results will support Abbott's application for U.S. Food and Drug Administration (FDA) approval for pediatric use in the U.S.
See more about the AMPLATZER Device on Meddevicetracker.
iCAD Announces Approval of Xoft Axxent Balloon Applicatord by China Food and Drug Administration for Treatment of Early-Stage Breast Cancer
iCAD announced that the company's Xoft Axxent balloon applicators have received approval from the China Food & Drug Administration (CFDA) for the treatment of early-stage breast cancer. The Xoft Axxent balloon applicators are a key component of the Xoft Axxent Electronic Brachytherapy (eBx) System, which is used to perform intraoperative radiation therapy (IORT) in early-stage breast cancer patients who meet specific selection criteria. With this CFDA approval, the complete suite of Xoft System products is now available to clinicians and patients in China.
IORT with the Xoft System allows radiation oncologists and breast surgeons to work together to deliver a full course of radiation to the tumor site at the time of lumpectomy. The balloon applicator is used to deliver a single, precise dose of radiation to the lumpectomy cavity, directly targeting cancer cells while minimizing exposure to healthy surrounding tissue. In the procedure, the Xoft System's miniaturized x-ray source is inserted into the balloon applicator, providing a channel to deliver high-dose rate, low energy radiation treatment. The balloon applicator is available in multiple sizes and shapes, can be filled with different volumes of saline to best fit the contour of the surgical cavity, and allows delivery of a more conformal radiation dose.
The Xoft System is FDA-cleared for the treatment of cancer anywhere in the body, including early-stage breast cancer, non-melanoma skin cancer and gynecological cancers.
See more about the Xoft Axxent Balloon Applicator at Meddevicetracker.
August 31, 2017
Abbott Freestyle Libre Glucose Monitoring System Granted National Reimbursement in Japan
Abbott announced that the Ministry of Health Labour and Welfare (MHLW) in Japan has granted national reimbursement for the FreeStyle Libre glucose monitoring system effective September 1, 2017. The revolutionary system will be widely available to the more than 1 million Japanese people ages six and above with diabetes, both Type 1 and Type 2, on insulin therapy.
Japan has one of the highest rates of diabetes with an overall population of 9.5 million people living with the condition.
Abbott's FreeStyle Libre system helps address the challenges of routine finger sticking for people with diabetes with a quick one second scan over a small sensor that is worn on the back of the upper arm. In addition, no finger stick calibration is needed— a key differentiator from current continuous glucose monitoring systems. With the data from the device, users can have a better understanding of their glucose levels through the Ambulatory Glucose Profile (AGP), a chart that provides a visual snapshot of glucose levels, trends and patterns over time. The AGP also provides doctors with deeper insights to make more informed treatment decisions.
Two published clinical trial3 and real-world evidence from more than 50,0004 users show that people who use FreeStyle Libre system test their glucose levels an average of at least 15 times per day. The studies also show that people who scan more frequently spend less time in hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) while having improved average glucose levels, demonstrating improved glucose control overall.
Abbott's FreeStyle Libre system was introduced across Europe in 2014, and is now available in 39 countries. Japan now joins a group of 16 countries that have partially or fully covered Libre, including large markets such as France and Germany. In the U.S., the FreeStyle Libre system is currently under review by the U.S. Food and Drug Administration.
See more about the FreeStyle Libre System at Meddevicetracker.
Apollo Endosurgery Announces 20-year LAP-BAND Outcomes Data Presented at 22nd IFSO World Congress in London
Apollo Endosurgery announced the presentation of 20 year outcomes data for the LAP-BAND System today at the 22nd World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) in London.
Paul O’Brien, MD and his colleagues reported on the follow up of 8,263 gastric banding patients treated using the LAP-BAND between September 1994 and June 2017 at the Centre for Bariatric Surgery (CBS) in Melbourne, Australia. Key data reported:
- An overall follow-up rate of 58%.
- Total weight loss for patients out to 20 years was 26.9 kg (59.3 lb), which represents loss of 48.2% of their excess weight.
- The overall explant rate for the entire patient population was 7.9%, with an explant rate of 4.6% for procedures performed in the period between 2006 and 2017, when CBS used the current version of the LAP-BAND (LAP-BAND AP Adjustable Gastric Band System).
- In addition, there were no mortalities among all procedures performed, which included primary and re-operation procedures.
These excellent long-term outcomes provide further evidence that LAP-BAND is a safe and effective procedure that results in sustained, medically relevant weight loss.
See more about the LAP-BAND System at Meddevicetracker.
September 1, 2017
HeartSciences MyoVista High Sensitivity ECG Now Available in Europe
HeartSciences is releasing in Europe its MyoVista high sensitivity electrocardiograph (hsECG) device that helps to screen patients for cardiac disease. It relies on a mathematical method known as continuous wavelet transform to process ECG data in a manner very different than conventional ECG. The company compares the way its MyoVista’s color representation of the heart gives a view of the heart’s distribution of energy to color Doppler radar giving a view into the energy distribution of a storm.
Early detection of cardiac conditions can significantly lower the later burden on patients as well as healthcare systems, and MyoVista claims some impressive capabilities. For example, according to HeartSciences, in a 200 patient trial looking for left ventricular diastolic dysfunction, the system “detected cardiac dysfunction in the resting (diastolic) phase of the cardiac cycle with 88 percent sensitivity and 87 percent specificity.” This was partially thanks to a machine learning algorithm that was used to process the data on top of MyoVista’s standard processing.
See more about the MyoVista Device at Meddevicetracker.
Adherium Receives U.S. 510(K) Clearance for Next Generation Smartinhaler for AstraZeneca’s Symbicort Aerosol Inhaler
Adherium announced U.S. Food and Drug Administration (FDA) 510(K) clearance for its new SmartTouch for Symbicort inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler.
The SmartTouch for Symbicort is a device installed onto a patient’s inhaler to monitor and encourage medication adherence as part of a self-management plan. It is the latest product to be added to Adherium’s product portfolio to assist patients, who suffer from respiratory conditions such as asthma and COPD, with adherence.
Adherence to medication is crucial for the successful management of many chronic diseases, but it is common for patients with respiratory conditions to only take between one third and one half of their prescribed medications.
The next generation device records the date and time the inhaler is used and automatically transmits this information to an app on the patient’s phone or tablet. The SmartTouch stores the history of patient medication usage patterns, allowing physicians to also review the information and help make evidence-based decisions on how best to meet the patient’s needs. The SmartTouch can be used in home monitoring programs, such as hospital re-admission prevention programs, where maintaining medication adherence after hospital discharge is a key objective.
SmartTouch for Symbicort is designed to make inhaler installation and removal easy for all patients, especially older patients with COPD. The SmartTouch design includes three buttons that help patients easily access the audio visual-reminders, battery monitoring, and Bluetooth low-energy (BLE) pairing features.
The company recently announced the sale of its 100,000th Smartinhaler.
See more about the Smartinhaler at Meddevicetracker.com