Meril Life Sciences wins approval for TAVR in India
Meril Life Sciences’ MyVal TAVR device
Indian medtech maker Meril Life Sciences has won regulatory approval for a transcatheter aortic valve replacement (TAVR) developed exclusively in India, according to a published report.
The MyVal device is balloon-expandable and employs a hybrid honeycomb cell design. The upper, open cells were designed to ensure un-jailing of coronary ostia, and the closed, lower cells offer high radial strength, according to the company’s website.
India’s Central Drugs Standard Control Organisation granted the MyVal device approval for commercialization last month, according to a r...
Source: Mass Device - December 7, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Central Drugs Standard Control Organisation Meril Life Science Source Type: news
Is 2019 Going to Be a Standout Year for TAVR?
JenaValve has won a nod from FDA for expanded IDE enrollment of its transcatheter aortic valve replacement (TAVR) system. The agency’s nod is aimed at feasibility studies for the JenaValve Pericardial TAVR System with the Everdur transcatheter heart valve and expands eligible enrollment from 20 patients to 80 at high or extreme surgical risk.
The Irvine, CA-based company said the prospective IDE studies are part of a larger, ongoing CE Mark clinical program investigating the JenaValve Pericardial TAVR System for the same indications at centers of excellence in Europe and New Zealand.
Approval for addition...
Source: MDDI - December 4, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news
Pivotal trial kicks off for Edwards Lifesciences ’ Pascal mitral repair device
A pivotal trial of Edwards Lifesciences’ (NYSE:EW)Pascal mitral valve repair system is now underway, with the first procedure being performed this week at Atlantic Health System’s Morristown Medical Center, the group said.
The study, dubbed the Clasp IID trial, will explore the safety and efficacy of Irvine, Calif.-based company’s Pascal TMVR system in treating patients with degenerative mitral valve regurgitation, the research institution said.
“As a nationally ranked heart hospital, Morristown Medical Center is proud to be the first hospital in the world to implant this device as part of this piv...
Source: Mass Device - December 4, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Source Type: news
Uganda: 150 Children to Get Free Heart Surgeries
[Monitor] Kampala -A total of 150 children suffering from Rheumatic Heart Disease (RHD), a fatal condition which damages heart valves, will receive free surgeries starting January next year. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - December 4, 2018 Category: African Health Source Type: news
FDA OKs expanded JenaValve study
JenaValve Technology said today that the FDA approved the expansion of its investigational device exemption trials for the transcatheter aortic valve replacement it’s developing.
The JenaValve system consists of the Everdur valve and Coronatix delivery catheter. The FDA decision expands the feasibility study from 20 extreme- or high-risk patients to 80 patients with either aortic stenosis or aortic regurgitation, the Irvine, Calif.-based company said. JenaValve said the IDE studies are part of its larger CE Mark program in Europe and New Zealand.
“We are extremely pleased with the initial clinical results, a...
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Featured Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves JenaValve Source Type: news
