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CE mark approval for Biosensors’ Imperia THV delivery system - Cardiovascular News

Biosensors International has received CE mark certification for the Imperia delivery system under the EU Medical Device Regulation (MDR). The Imperia delivery system is part of the Allegra transcatheter heart valve (THV) system and is intended for the transfemoral implantation of the already CE-marked Allegra THV, indicated for the treatment of severe aortic stenosis. The new delivery system emphasises ease of use while maintaining maximum safet…
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Cardiovascular News broke the news in on Monday, July 14, 2025.
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