JenaValve Raises $100 Million
WEBAug 31, 2022 · JenaValve received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) to facilitate the review of ALIGN-AR, a pivotal trial in the U.S., as part of its premarket approval (“PMA”) application for the Trilogy Heart Valve System for the treatment of symptomatic, severe aortic regurgitation (AR) in …
Feature | Transcatheter Heart Valve Technology: An Update
WEBSep 28, 2023 · A fifth valve, the JenaValve (JenaValve Technology), is also approved in the EU and has breakthrough-device designation and an investigational device exemption from the FDA, but this valve is being developed primarily for …
Enrollment ends for ALIGN-AR IDE Trial : JenaValve
WEBSep 14, 2022 · JenaValve received Breakthrough Device Designation by the FDA to facilitate the review of ALIGN-AR, a pivotal trial in the U.S., as part of its PMA application for the Trilogy Heart Valve System for the treatment of ssAR in high surgical risk patients.
JenaValve nabs $100M to clear TAVR system’s FDA pathway
WEBAug 31, 2022 · Stateside, JenaValve received an investigational device exemption from the FDA in August 2021, giving it the go-ahead to begin a clinical trial of the Trilogy system—the results of which will be...
JenaValve Receives CE Mark for Trilogy™
WEBThe Trilogy Heart Valve System is the first transfemoral device of its kind to receive CE mark approval for the treatment of both severe symptomatic aortic regurgitation and aortic stenosis.
Transfemoral TAVI device gains US FDA breakthrough status for …
WEBAug 1, 2023 · Genesis MedTech has announced that its J-Valve transfemoral (TF) system has been granted breakthrough device designation by the US Food and Drug Administration (FDA).
JenaValve Announces First Trilogy Heart Valve Systems
WEBMay 18, 2023 · JenaValve received Breakthrough Device Designation from the FDA to facilitate the review of ALIGN-AR, a pivotal trial in the U.S., as part of its PMA application for the Trilogy Heart Valve...
JenaValve Completes Enrollment in the ALIGN-AR IDE Clinical Trial
WEBSep 14, 2022 · JenaValve received Breakthrough Device Designation by the FDA to facilitate the review of ALIGN-AR, a pivotal trial in the U.S., as part of its PMA application for the Trilogy Heart Valve...
JenaValve TAVR tech amid wave to get breakthrough device status from ...
WEBJan 10, 2020 · FDA has granted breakthrough device designation to a transcatheter aortic valve replacement system in development at JenaValve Technology, the company said Thursday.
JenaValve Transcatheter Aortic Valve Replacement (TAVR) System ...
WEBJan 9, 2020 · JenaValve Pericardial TAVR System is the First Transcatheter Device to Achieve Breakthrough Device Designation; Prioritizes Premarket Approval Development Path for Severe Aortic...