GlobalData on MSN

JenaValve strikes US market first with approval in TAVR-AR indication

The FDA PMA for JenaValve's Trilogy device for TAVR-AR comes months after a court struck down Edwards Lifesciences attempt to ...
MassDevice

JenaValve wins FDA nod for Trilogy heart valve system

JenaValve announced today that it has received FDA premarket approval (PMA) for its Trilogy transcatheter heart valve system.

JenaValve Announces FDA Approval of the Trilogy™ Transcatheter Heart Valve System — the First and Only Transcatheter Device Approved for Symptomatic, Severe Aortic ...

JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket ...
Medical Device and Diagnostic Industry (MD+DI)

A New Era in Aortic Regurgitation Treatment with JenaValve Trilogy System

JenaValve's Trilogy System, FDA-approved for severe AR, offers secure anchoring without calcium. It is a breakthrough for ...
MedTech Intelligence

JenaValve Gets FDA Nod for Trilogy Transcatheter Heart Valve (THV) to Treat Aortic Regurgitation (ssAR)

With its FDA approval, JenaValve intends to commence launch activity for the Trilogy System immediately with participating ...
MedPage Today on MSN

First TAVR system approved for severe aortic regurgitation

Limited launch expected for JenaValve's Trilogy System ...
TCTMD

ALIGN-AR at 2 Years Shows Promise for TAVI With Trilogy in Aortic Regurgitation

WASHINGTON, DC—Further follow-up from the ALIGN-AR trial confirm the safety and continued efficacy of the Trilogy heart valve system (JenaValve) for the treatment of patients with severe, symptomatic ...