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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

Edwards launches US pivotal Centera self-expanding TAVR study
Edwards Lifesciences (NYSE:EW) said yesterday it launched a U.S.-based pivotal trial of its self-expanding Centera transcatheter aortic valve, exploring its use in treating severe symptomatic aortic stenosis in intermediate risk patients. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Edwards said. The Irvine, Calif.-based company said it hopes to enroll approximately 1,000 patients in the trial, which will include a bicuspid registry. The endpoint fo...
Source: Mass Device - October 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news

Edwards Lifesciences wins CE Mark for Centera TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Irvine, Calif.-based company said. “With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-expanding ...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

Rapid Medical launches Tigertriever registry study
Neurovascular device maker Rapid Medical said it launched a registry study of its Tigertreiver controllable stent retriever. The Israel-based company touts the Tigertriever as the only controllable, fully-visible stent retriever which can be adjusted by the physician to fit in the dimensions of the blocked blood vessel. The newly launched European multi-center registry study looks to enroll patients in France and Switzerland, and will be the 1st to examine the use of the Tigertriever in a real-life setting. The company said it has enrolled its 1st patient in the trial at Switzerland’s Cantonal Hospital of Lucerne. ...
Source: Mass Device - September 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Stents rapidmedical Source Type: news

MassDevice.com +5 | The top 5 medtech stories for September 15, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. FDA cuts could threaten medtech innovation: Here’s why The Trump administration’s proposed federal budget could hurt the speed and quality of FDA review times, says a top expert at Musculoskeletal Clinical Regulatory Advise...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Studies support anti-stroke PFO closure devices from Abbott, Gore
Sykes and Clark; licensee BioMed Central Ltd. A trio of studies published this week in the New England Journal of Medicine showed that devices from Abbott (NYSE:ABT) and W.L. Gore & Assoc. designed to close a heart defect lowered the risk of a recurring episode in certain cryptogenic stroke patients. Long-term results from the 980-patient Respect trial of the Amplatzer device Abbott acquired along with St. Jude Medical this year, along with data from the Reduce study of Gore’s Helex and Cardioform and the French Close study of PFO closure devices with CE Mark approval, showed that they reduced the risk of recurr...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Surgical Abbott Structural heart W.L. Gore & Associates Source Type: news

Keystone Heart looks to launch 3rd-gen TriGuard trials in 2017
Keystone Heart  said yesterday it plans to launch a clinical trial of a 3rd-generation TriGuard cerebral embolic protection device by the end of the year. The Israel-based company said the new device, dubbed the TriGuard 3, will offer technological improvements over previous versions of the device, and that it has accelerated the development program of the device. Keystone Heart’s TriGuard devices are designed to protect the brain from emboli during transcatheter aortic valve replacement and other heart procedures to reduce stroke risk and brain damage. The TriGuard 3 is designed to be anatomy independent and for a ...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Neurological Research & Development Keystone Heart Source Type: news

ReWalk Robotics inks French distro deal with Harmonie M édical Service
ReWalk Robotics (NSDQ:RWLK) said today it inked an exclusive French distribution deal with Harmonie Médical Service. Through the deal, HMS will operate as sole distributor of the ReWalk exoskeleton systems for individuals with spinal cord injuries in France. The deal includes both the ReWalk Personal and ReWalk Rehabilitation systems for home and clinical use, respectively. “Our partnership with ReWalk is a real opportunity for HMS. We have been working for 30 years in the medical materials domain with people who have lost their mobility. We have always looked for innovative technologies in this domain, especially...
Source: Mass Device - July 11, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Robotics ReWalk Robotics Source Type: news