Biosensors Imperia Delivery System Receives CE Mark Approval

July 17, 2025—Biosensors International recently announced it received CE Mark certification for the Imperia delivery system under the European Union Medical Device Regulation 2017/745. The Imperia device is now commercially available across Europe.

According to the company, the Imperia device is part of the Biosensors Allegra self-expanding, supra-annular, transcatheter heart valve (THV). Allegra is intended for transfemoral implantation of the CE Mark–approved Allegra, which is indicated for the treatment of severe aortic stenosis.

Biosensors advised that the new delivery system enables recapturability, repositioning, and retrievability of the Allegra valve. The system is intended to allow interventional cardiologists to adapt to varying patient anatomies, achieve precise valve implantation, and optimize hemodynamic performance postimplantation.

The company noted that the Allegra THV system with the Imperia delivery system was evaluated in the EMPIRE study. The 30-day results, which were presented at PCR London Valves 2024, demonstrated high procedural success, user-friendliness, and excellent hemodynamic performance of the valve.

José Antonio Baz, MD, of Vigo, Spain, is Principal Investigator of the EMPIRE study.

“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,” commented Dr. Baz in the company’s press release. “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 Allegra THV system received CE Mark approval and was launched in 2017. In 2020, the system received CE Mark approval for the valve-in-valve treatment of degenerated surgical aortic valves.

The company noted that Allegra originated from Switzerland-based NVT AG, which was acquired by Singapore-based Blue Sail Medical in 2020 and then joined Biosensors International Group, a subsidiary of Blue Sail.