The FDA PMA for JenaValve's Trilogy device for TAVR-AR comes months after a court struck down Edwards Lifesciences attempt to ...
JenaValve announced today that it has received FDA premarket approval (PMA) for its Trilogy transcatheter heart valve system.
This marks the first dedicated transcatheter heart valve approved for high-risk patients with symptomatic severe AR.
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 ...
JenaValve's Trilogy System, FDA-approved for severe AR, offers secure anchoring without calcium. It is a breakthrough for ...
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 ...
With its FDA approval, JenaValve intends to commence launch activity for the Trilogy System immediately with participating ...
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