The FDA PMA for JenaValve's Trilogy device for TAVR-AR comes months after a court struck down Edwards Lifesciences attempt to ...
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 announced today that it has received FDA premarket approval (PMA) for its Trilogy transcatheter heart valve system.
JenaValve's Trilogy System, FDA-approved for severe AR, offers secure anchoring without calcium. It is a breakthrough for ...
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First TAVR system approved for severe aortic regurgitation
Limited launch expected for JenaValve's Trilogy System ...
With its FDA approval, JenaValve intends to commence launch activity for the Trilogy System immediately with participating ...
Patients who underwent transcatheter aortic valve replacement (TAVR) with a valve designed to treat aortic regurgitation had an overall mortality rate of just 8.1% at one year, well below the trial's ...
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 ...
Patients who underwent transcatheter aortic valve replacement (TAVR) with a valve designed to treat aortic regurgitation had an overall mortality rate of just 8.1% at one year, well below the trial's ...
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