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 safety and procedural predictability, a press release from Biosensors International states. The system enables recapturability, repositioning, and retrievability of the Allegra valve, facilitating precise valve implantation. This contributes to optimised haemodynamic performance post-implantation, the company press release adds.
Yu Suhua, chief executive officer of Biosensors International, stated: “We are excited to launch this new transfemoral delivery system and expand its availability to all countries and regions currently utilising our THV system. The proven benefits of the Allegra valve, combined with the advanced features of the Imperia delivery system, will help interventional cardiologists further enhance clinical outcomes for patients requiring aortic valve replacement.”
The Allegra THV system with the Imperia delivery system was investigated in the EMPIRE study (24–26 November, London, UK). Thirty-day results, presented at PCR London Valves 2024, demonstrated high procedural success, user-friendliness, and excellent haemodynamic performance of the valve, the company’s press release states.
José Antonio Baz Alonso (Hospital Álvaro Cunqueiro, Vigo, Spain), principal investigator of the EMPIRE study, commented: “During the EMPIRE study, we were impressed by the seamless performance of the new delivery system across a wide range of anatomies and clinical indications. Importantly, the study reported no cases of moderate or severe patient-prosthesis mismatch (PPM) at 30 days in the native cohort. This outcome highlights a valuable option for treating patients with small to medium annulus sizes, supporting the reduction of PPM and potentially improving long-term mortality outcomes.”
The Imperia delivery system is now commercially available across Europe with immediate effect.
