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September 18, 2017

iVascular Presents 6 Month Results from EffPAC at CIRSE 2017


iVascular presented data from the EffPac Study in an abstract titled "EffPac Trial: Effectiveness of paclitaxel-coated Luminor balloon catheter versus uncoated balloon catheter in the femoropopliteal artery to prevent vessel restenosis or reocclusion: Primary endpoint and 6 months follow-up" at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Conference on September 18, 2017.



The EffPac study was a multicenter randomized-controlled trial to evaluate Luminor Paclitaxel-coated DEB catheter of stenotic or occlusive lesions (length: ≤15 cm) in the superficial femoral artery (SFA) and popliteal artery (PA) up to the P1 segment compared to non-coated plain old angioplasty balloon (POBA) catheter. In total 172 subjects will be treated with either DEB or POBA in 11 German study centers in a 1:1 randomization study design.



Primary endpoint is late lumen loss (LLL) at 6 months. Secondary endpoints are patency rate, target lesion/vessel revascularization, quality of life (assessed with Walking Impairment Questionnaire (WIQ) and EQ5D), change of Rutherford stage and ankle-brachial index, major and minor amputation rate at index limb, number of bailouts and all-cause mortality.



Primary and secondary endpoints were achieved with high statistical significance:


  • Primary endpoint revealed a late lumen loss (LLL) of 0.14mm in the DCB group vs 1.06mm in the POBA group (p<0.001).
  • Target Lesions Revascularization (TLR) was 1.3% (DCB) vs 17.1% (POBA) (p<0.001).
  • Primary Patency (PP) was 94.7% (DCB) vs 75.0% (POBA) (p<0.001).
  • Rutherford stages were overall improved for 85.2% patients (DCB) vs 75.0% (POBA) (p=0.021), and by 3 stages for 44.6% patients (DCB) vs 27.8% (POBA)



There was no amputation nor any product related adverse event in the DCB group.



EffPac represents a randomized controlled trial that will provide evidence on the effectiveness of Luminor Paclitaxel-coated DEB catheter for the reduction of restenosis compared to POBA of SFA and PA. The results of EffPac will allow direct comparison to other already-completed RCTs applying Paclitaxel-coated DEB from different manufactures in the same target vessel.



See more about the Luminor Paclitaxel-Eluting PTA Dilatation Catheter on Meddevicetracker.



Medtronic Launches Next Generation Spinal Cord Stimulator


Medtronic announced FDA approval and U.S. launch of the Intellis platform for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance, and can power the EvolveSM workflow, which standardizes guidance and balances high-dose (HD) and low-dose (LD) therapy settings. The Intellis platform can record and track patient activity 24/7 and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physicians to address the subjective and personal nature of chronic pain by monitoring progress and making modifications to better suit their patients' therapy needs.



Duke University Medical Center in Durham, N.C. implanted one of the first patients in the U.S. with the Intellis device.



See more about the Intellis SCS on Meddevicetracker.




September 19, 2017

Delcath Presents Data on the CHEMOSAT System at CIRSE 2017


Delcath announced that the results of a single institution study were presented during a scientific session in an abstract titled "Prospective clinical and pharmacological evaluation of the Delcath System’s second generation (GEN2) hemofiltration system in patients undergoing percutaneous hepatic perfusion with melphalan" at the Cardiology and Interventional Radiology of Europe (CIRSE) annual meeting on September 19, 2017 in Copenhagen, Denmark.



Data from this study were previously seen in September 2016.



From February 2014, two prospective Phase II studies were initiated in patients with hepatic metastases from ocular melanoma or colorectal cancer. In 10 PHP procedures performed in the first 7 enrolled patients, blood samples were obtained to determine filter efficiency and systemic drug exposure. PHP was performed with melphalan 3 mg/kg with a maximum dose of 220 mg. Complications were assessed according to CTCAE v4.03. Response was assessed according to RECIST 1.1.



Pharmacokinetic analysis of blood samples showed an overall filter efficiency of 86% (range 71.1%–95.5%). The mean filter efficiency decreased from 95.4% 10 minutes after the start of melphalan infusion to 77.5% at the end of the procedure (p=0.051). Bone marrow depression was observed after up to 80.0% in 10 procedures, but was self-limiting and mostly asymptomatic. No hypotension related complications or procedure-related mortality occurred.



The GEN2 filter had a higher melphalan filter efficiency than the first-generation filter and a more consistent performance. PHP with the GEN2 filter appears to have an acceptable safety profile, but this needs further validation in larger studies.



See more about the Delcath Hepatic Delivery System on Meddevicetracker.



Rapid Medical Enrolls First Patient in TIGERTRIEVER Registry


Rapid Medical announced that the first patient was enrolled to the TIGERTRIEVR registry at the Cantonal Hospital of Lucerne, Switzerland. The TIGERTRIEVER registry is a European multi-center registry that will enroll patients from leading centers in France and Switzerland. It is the first registry that is designed to demonstrate the benefits of the TIGERTRIEVER in real-life usage.



The first patient treated was an 87-year-old male admitted to the hospital with an acute stroke, suffering from severe aphasia and right sided hemiplegia. The patient was treated with the TIGERTRIEVER which removed a large clot from his left internal carotid artery in a single attempt. The procedure went very well and took 19 minutes, including placement of a carotid stent due to a severe carotid stenosis. The patient recovered quickly and completely and was even able to sign his consent, to be enrolled in this registry study, one hour after finishing the procedure.



In addition to the post marketing registry, Rapid Medical plans to initiate a prospective multi-center clinical study for FDA clearance for the TIGERTRIEVER. The TIGER study is planned to start enrolling patients in leading centers in US, Europe and Israel during the first half of 2018.



See more about the Tigertriever on Meddevicetracker.



September 20, 2017


DarioHealth Partners with Innovation Hub HighTechXL



DarioHealth and HighTechXL, a corporate-backed accelerator based in Eindhoven, The Netherlands, announced a strategic collaboration to bring personalized healthcare management to diabetes and pre-diabetes patients around the world.



Backed by an alliance of corporations and regional organizations, including Philips, the HighTechXL Acceleration program selected DarioHealth because of its strong management team, innovative business model, and smart solutions for diabetes management. DarioHealth develops cloud-based diabetes platforms that include a native mobile solution helping patients to manage diabetes related information and a platform that facilitates coaching. The all-in-one Dario Blood Glucose Monitoring System is capable of sharing real-time results with healthcare professionals via the personalized AI-driven application.



The HighTechXL Accelerator is a three-month, corporate-backed program designed to accelerate startups to their next stage of development, including to help them gain broader customer traction and secure development partnerships. In addition, the program team facilitates the possibility for scaling companies to explore options including starting a pilot project with the corporations constituting the HighTechXL partner network, or integrating their product or service into the corporation's existing business line.



For the selection of its latest batch, the HighTechXL team invited 75 startups and scale-ups from 23 different countries. Selected companies were invited to participate in a joint three-day selection event by HighTechXL and Get in the Ring in collaboration with ABN AMRO bank, ASML, EY, NTS-Group, and Philips. 35 of the 75 companies were focused on the development of healthcare solutions and medical devices. DarioHealth competed in a medical technology track, during which companies were given the opportunity to assess the fit of their business and technology propositions against Philip's current product lines with executives and innovation managers.



Globally, DarioHealth is already cleared by four major regulatory bodies including Health Canada, CE, TGA, and the U.S. FDA for both iOS and certain Android devices. The product is available in the United States, United Kingdom, Australia, Canada, New Zealand, The Netherlands, Israel, and Italy. In addition, DarioHealth has received reimbursement coverage for plans in the United Kingdom, Australia, Italy, and Canada, and is also covered by 3rd-party insurance agreements in the United States.



See more about the Dario Diabetes Management Solution App on Meddevicetracker.



Abiomed Receives PMA Approval for Impella RP

Abiomed announced it has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP heart pump. Culminating from five years of research, this approval follows the prior FDA Humanitarian Device Exemption (HDE) received in January 2015 and adds the Impella RP heart pump to Abiomed's platform of PMA approved devices.



With this approval, Abiomed claims that the Impella RP heart pump is the only percutaneous temporary ventricular support device that is FDA-approved as safe and effective for right heart failure as stated in the indication:



The Impella RP System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.



Data submitted to the FDA in support of the Impella RP heart pump PMA included the RECOVER RIGHT FDA-approved, prospective, multicenter, single-arm study, which commenced after the company received FDA investigational device exemption (IDE) approval in November 2012 and concluded in 2014. Since that time, Abiomed completed a Continuous Access Protocol (CAP) as well as a prospective, multicenter post-approval study (PAS). These data were presented in the plenary session of the 2017 Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation. The Impella RP heart pump is reimbursed by Medicare and other major payers. Abiomed will complete a PMA post-approval study with 60 consecutive patients in Abiomed's Institutional Review Board (IRB)-approved, FDA audited prospective cVAD Registry.



The Impella RP heart pump stabilizes the patient's hemodynamics, unloads the right ventricle and allows for native heart recovery. Delivered through a catheter requiring only a small hole in the leg, the Impella RP heart pump is designed to provide the flow and pressure needed to compensate for right heart failure. The device does not require a surgical procedure for insertion, and it provides more than four liters of blood per minute for hemodynamic support.



See more about the Impella RP on Meddevicetracker.



September 21, 2017

Avita Medical Executes Contract Option with BARDA


Avita Medical announced the execution of an expanded contract option valued at approximately US$24.3 million. This newly executed contract option establishes funding for key clinical and health economics research in U.S. pediatric burn care and extends Avita’s Project Bioshield contract through to September 2022. The option execution relates to an original contract between Avita Medical and the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (ASPR).



Avita Medical has had a strong relationship with BARDA since the execution of a five-year contract in September 2015. Under the base contract BARDA made an initial investment of US$16.9 million to support Avita’s ongoing U.S. clinical regulatory program towards FDA Premarket Approval (PMA), and to procure 5,000-plus ReCell devices.



The contract also allowed BARDA to exercise future options to support additional clinical trials, and provide surge capacity for up to another 20,000 ReCell devices. Supplemental funding worth up to US$7.96 million was also provided to Avita under the contract in June of 2016, to provide further operational support to Avita’s PMA preparation and Compassionate Use program. Both objectives support BARDA's overarching goal of building burn care preparedness, by securing effective medical countermeasures for burn injuries for use in case of a mass casualty. The base contract between BARDA and Avita Medical has provided substantial support to the shared primary goals of achieving U.S. regulatory approval for the Company’s ReCell Autologous Cell Harvesting Device thus establishing preparedness for a potential U.S. mass casualty event involving thermal burn injuries. Pediatric burn care is of particular concern to BARDA and Avita, as the primary modality for treatment continues to involve harvesting the patient’s own skin for autografts. Pediatric use is of interest to BARDA because medical countermeasure (MCM) development must include at-risk, vulnerable populations such as children.



Two randomized control trials (RCTs), powered to demonstrate statistical significance, have been presented to the FDA via the pre-submission process. One trial focuses on characterizing benefit derived from use of Regenerative Epithelial Suspension prepared using the ReCell device to treat donor sites in patients aged 1 to 16 years. The other trial, planned to run in parallel, will aim to show decreases both in time to healing and in the frequency of conventional autografting in patients of the same age range who have suffered second-degree burn injuries. The two-cohort study design, planned to include collection of costing data in addition to clinical data, will further inform both clinical and health economic benefits of using ReCell. Both studies will compare treatment using the ReCell device versus current standard approaches. Up to twenty U.S. burn centers may be involved in recruiting patients into these studies.



See more about the ReCell Device on Meddevicetracker.



Nemaura Announces Interim Results for sugarBEAT


Nemaura Medical announced interim clinical trial results for the sugarBEAT European clinical trial programme. The trials are expected to determine safety, accuracy, precision and utility of sugarBEAT as an adjunct to finger stick testing, and is expected to be completed over the next ten weeks. Nemaura anticipates launching sugarBEAT in the UK shortly after completion of this clinical trial programme.



This clinical trial programme consists of a total of 525 patient days, comprising 75 patients continuously wearing sugarBEAT for up to 14 hours per day over 7 consecutive days in a combination of home and clinic settings.



Interim results based on 175 patient days completed thus far have detected no skin irritation or serious adverse events. Minor adverse events were reported in the form of skin-patch de-lamination due to high humidity weather conditions, and were addressed by using an over-strip of adhesive or use of elastic arm band.



The data generated thus far has indicated accuracy that is comparable to, and non-inferior to that previously achieved by the wired wrist worn predecessor SugarBEAT device, which received a CE mark in 2016.



Further clinical studies are planned including those for FDA approval in the US, and to investigate the use of sugarBEAT in critical care settings.


See more about the sugarBEAT on Meddevicetracker.




September 22, 2017

Abbott Announces FDA Approval for MRI Compatibility of Ellipse

Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for the Ellipse implantable cardioverter defibrillator (ICD) with the Tendril MRI pacing lead and Durata and Optisure high voltage leads. The new MR-conditional labeling for the Ellipse ICD allows patients to undergo an MRI scan if needed. In addition, patients previously implanted with an Ellipse device and Durata or Optisure leads can now undergo MRI scans.



Abbott submitted the supplemental premarket approval (PMA) application in March 2017.



When electrical signals in the lower chamber of the heart fire erratically, the heart can beat abnormally fast – a condition known as ventricular tachycardia or tachyarrhythmia – which in turn leaves the heart unable to pump blood effectively. In addition to symptoms such as light-headedness, chest pains and shortness of breath, over time the condition can lead to a potentially life-threatening arrhythmia, heart failure, stroke or cardiac arrest. Abbott's ICD devices can monitor for and detect abnormally fast heart rhythms and deliver electricity to the heart to restore the heart's natural rhythm.



The smaller shape and size of Ellipse ICD helps improve patient comfort once implanted and Abbott engineered the device with features designed to optimize ICD therapy and improve patient safety. The features, known as Abbott's TailoredTherapy approach, include:



  • DeFT Response Technology: Allows physicians to adapt how therapy is delivered by the Ellipse ICD to ensure each patient receives therapy based on their unique need. The feature also helps ensure successful therapy delivery without the need to deliver an initial shock at the time of implant.
  • SecureSense: Abbott's SecureSense algorithm offers an additional level of protection for patients by providing proper sensing within the heart even in the presence of external interference (known as "lead noise") to safeguard against unnecessary therapy being delivered to the patient.
  • DynamicTx: With Abbott's DynamicTx algorithm, physicians can be confident that their patient's devices are consistently evaluating the condition of the lead and adapting the path of the electrical impulse to deliver appropriate therapy. As a further benefit, all therapy and other data captured by the Ellipse ICD can be directly, securely and wirelessly sent to a patient's physician through the Patient Care Network. This communication allows physicians to remotely monitor their patient's therapy and assess any need for intervention.



The latest labeling ensuring Abbott's Ellipse ICD is MRI ready follows approval earlier this year of Abbott's Assurity MRI pacemaker and prior MR-conditional labeling approvals in Europe, allowing Abbott to further build its portfolio of MRI ready products. The company continues to work with regulatory agencies around the world to secure approval for MR-conditional labeling for additional commonly-implanted pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices.



See more about the Ellipse ICD on Meddevicetracker.


Elekta and Brainlab Announce Collaboration


Elekta and Brainlab have reconfirmed their alliance for the integrated use of the Elekta Versa HD linear accelerator and Brainlab ExacTrac patient positioning and monitoring technology. The integration of these two technologies offers high definition stereotactic radiosurgery (HDRS) treatments with versatile patient positioning and monitoring through simplified workflows.



In September 2016, the companies announced an agreement designed to ensure the continuous evolution of interoperability and safety of Elekta’s Leksell Vantage Stereotactic System and Elements Stereotaxy treatment planning and verification software from Brainlab. The integrated use of both systems is designed to improve the safety and accuracy of stereotactic neurosurgical procedures. In June 2017, the companies announced that Brainlab would be the authorized distributor of Elekta’s stereotactic solutions for neurosurgery in selected markets.



See more about the Versa HD on Meddevicetracker.

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