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InspireMD touts results of ‘one-size-fits-all’ stroke-prevention study
InspireMD’s CGuard embolic prevention stent A clinical trial of  InspireMD’s (NYSE:NSPR) CGuard embolic prevention stent showed that it successfully treated patients whose carotid arteries varied in size, according to the company. The investigator-initiated trial in Germany used a 10 mm diameter CGuard stent with SmartFit technology across a broad range of carotid artery diameters. Variations in diameters of the common carotid artery (CCA) and the internal carotid artery (ICA), as well as inaccurate x-ray images caused by projection angles, make choosing the correct size choice of a carotid stent challenging, a...
Source: Mass Device - January 28, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials Implants Neurological News Well Research & Development Stents InspireMD Source Type: news

Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis. Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival Boston Scientific (NYSE:BSX). The company said that “the German court will hold a full hearing on the merits of the dispute” mid-next year, and that it is hopeful it will prevail. The company said it will introduce the Sapien 3 Ultra in the rest of Europe as pa...
Source: Mass Device - November 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Featured Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

Abiomed joins Protembis $10m Series A
Protembis said today it closed a $10 million Series A round, joined by cardiovascular device-focused Abiomed (NSDQ:ABMD), to support its embolic cerebral protection device. The round was joined by Abiomed, Aachen and Mönchengladbach GmbH’s Seed Fonds III and a number of family offices and angel investors, the Aachen, Germany-based company said. “Patient safety should always be our top priority. We see great potential in Protembis’ technology to make TAVI neurologically safer and thus enable TAVI to be used in an even larger patient population,” Abiomed chief technology officer Dr. Thorsten Siess ...
Source: Mass Device - October 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Funding Roundup Neurological Wall Street Beat Abiomed protembis Source Type: news

Neovasc touts Tiara TMVR success rate in study
A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation. Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study had had a previous aortic valve replacement. Such patients have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the TMVR anch...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiac Implants Cardiovascular Featured Replacement Heart Valves Research & Development Mayo Clinic neovasc Neovasc Inc. Source Type: news

Terumo ’ s MicroVention wins expanded FDA indications for Sofia cath
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today it won FDA clearance for a new clinical indication for its Sofia catheter designed for intracranial access, now cleared for contact aspiration procedures to treat acute ischemic stroke. The company said it won CE Mark approval in the European Union for the aspiration in 2015, and that the device has been used there and in other parts of the world to treat acute ischemic stroke. “In my clinical experience the unequaled tracking performance and the increased reperfusion capability of the Sofia Catheter make a major difference when treating patients suff...
Source: Mass Device - June 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Catheters Food & Drug Administration (FDA) Neurological Regulatory/Compliance Vascular MicroVention-Terumo Inc. Source Type: news

ReWalk Robotics inks $20m private placement, posts Q4, 2017 earnings
Shares in ReWalk Robotics (NSDQ:RWLK) have risen today after the company announced a $20 million private placement and posted shrinking losses for the quarter and growing sales for the year with its fourth quarter and 2017 earnings. The company said it inked an investment agreement with Hong Kong-based Timwell Corporation Limited through which the company will receive $20 million in three tranches through the issuance of 16 million shares at a price of $1.25 per share. The investment will come in three tranches, with $5 million for an initial 4 million shares in the first, $10 million for 8 million shares in the second an...
Source: Mass Device - March 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat ReWalk Robotics Source Type: news

EBR Systems launches trial for wireless pacer
EBR Systems said yesterday that it launched a 350-patient investigational device exemption trial of its Wise wireless pacemaker it hopes to use to win FDA approval. Sunnyvale, Calif.-based EBR’s device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle, which it uses to synchronize the left and right ventricles. The system is designed to eliminate the need for a left ventricular lead by allowing the operating physician to place the stimulation “pellet” in a patient-specific location inside the left ventricle. The FDA approved the Solve-CRT stu...
Source: Mass Device - March 8, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Cardiac Rhythm Management EBR Systems Inc. Source Type: news

Penumbra touts real-world study results in Penumbra System acute ischemic stroke trial
Penumbra (NYSE:PEN) today released results from the Promise real-world safety and efficacy study of its Penumbra System with ACE 68 and 64 reperfusion catheters as a treatment for patients with acute ischemic stroke, touting high rates of revascularization and low rates of all-cause mortality. Results were presented at the International Stroke Conference this week in Los Angeles. “We thank the Promise investigators for this important contribution to the growing body of global evidence supporting Adapt as a frontline approach for patients with acute ischemic stroke. The Promise study affirms our belief that the Penu...
Source: Mass Device - January 25, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Penumbra Inc. Source Type: news

Medtronic launches post-market study of CoreValve Evolut Pro heart valve
Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system. The multi-center, prospective single-arm study aims to enroll 600 patients across 35 European sites to evaluate the safety of the CoreValve Evolut Pro, including all-cause mortality and all stroke at 30 days and clinical performance including valve hemodynamics and paravalvular regurgitation. “We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut Pro valve in a...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Claret Medical touts Sentinel data in TAVR study
Claret Medical today released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortality rates. The study of the device was recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions, the Santa Rosa, Calif.-based company said. The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medical touts as the 1st and only FDA-cleared device to do so. “In pat...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Neurological Claret Medical Inc. Source Type: news

ESC 2017 Roundup: Biotronik touts lowered mortality for AF patients treated with cath ablation
Biotronik today released results from the Castle-AF study exploring the use of catheter ablation to treat heart failure patients with atrial fibrillation, touting a 38% composite reduction in all-cause mortality and hospitalization for worsening heart failure. The 398-patient, 33-site study compared the results of catheter ablation treatment for AF in heart failure patients using implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators to standard-of-care pharmacological therapy, the company said. Biotronik touted it as the largest study of its kind to date. Results indicated a 47% reduc...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Biotronik Medtronic Source Type: news

Medtronic readies pivotal trial in renal denervation
Medtronic (NYSE:MDT) said today that it’s ready for a run at FDA approval for renal denervation in treating high blood pressure, more than three years after the failure of a high-profile clinical trial. Back in January 2014, Fridley, Minn.-based Medtronic shocked medtech when it announced that the highly anticipated Symplicity HTN-3 trial, examining ablation of the around the renal arteries in treating hypertension, failed to meet its efficacy endpoint. The company suspended enrollment in its other Symplicity trials around the world and later took a $200 million write-down on its renal denervation assets. News of th...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Wall Street Beat Medtronic Renal Source Type: news

Myomo wins CE Mark for next-gen MyoPro powered orthotic
Myomo said today it won CE Mark approval in the European Union for its next-gen MyoPro myoelectric arm orthosis device. Cambridge, Mass.-based Myomo develops and produces myoelectric orthotics for patients with neuromuscular disorders, including its flagship MyoPro line. The orthosis devices are non-invasive, powered braces used to support weak or deformed arms and hands to allow for functional activity. Myomo touted the MyoPro as the only lightweight wearable device designed to restore function to paralyzed or weakened arms and hands in individuals who have suffered a stroke, spinal cord or nerve injury or other neuromus...
Source: Mass Device - July 31, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blog Myomo Inc Source Type: news