The FDA PMA for JenaValve's Trilogy device for TAVR-AR comes months after a court struck down Edwards Lifesciences attempt to ...
A randomized trial of Boston Scientific’s netlike Sentinel device—a miniature strainer designed to catch floating debris in the bloodstream before it can lodge itself within the brain and cause a ...
Limited launch expected for JenaValve's Trilogy System ...
The FDA has approved the Trilogy Transcatheter Heart Valve System for treating patients with symptomatic severe aortic ...
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Pi-Cardia received Food and Drug Administration clearance ...
Chief Executive Officer Wayne Paterson outlined the company’s DurAVR transcatheter aortic valve replacement (TAVR) program ...
The first day at the recently concluded Transcatheter Cardiovascular Therapies (TCT) meeting in Washington, D.C., was reportedly heavily focused on TAVR - transcatheter aortic valve replacement ...
The potential is high for TAVR adoption in emerging markets, according to Venkat Rajan, an analyst at Frost & Sullivan. “It is, however, coming in at a higher price point than traditional valves,” he ...
A device designed to remove embolic material—fragments of tissue that can be released into the bloodstream during transcatheter aortic valve replacement (TAVR)—did not result in a reduction in the ...
Indian-made Myval and Myval Octacor were put to the test against Sapien 3 in the noninferiority trial COMPARE TAVI-1. Noninferiority was demonstrated when counting deaths, strokes, moderate or severe ...
A US Food and Drug Administration (FDA) advisory panel struggled to muster support for marketing clearance of the TriGuard 3 (Keystone Heart) device for use during transcatheter aortic valve ...