NVT AG’s Allegra Transcatheter Aortic Valve Receives CE Mark Approval
April 3, 2017—NVT AG recently announced that it has obtained CE mark approval for its Allegra Transcatheter Aortic Valve (TAVR) system. According to the company, the system is approved for the treatment of severe calcified aortic valve stenosis in high-risk patients with elevated surgical risk.
The Allegra TAVR system is designed to improve the long-term survivability of patients by resolving the clinical issues associated with current commercial valves, said NVT in their announcement. The system consists of the Allegra transcatheter heart valve (THV) in three difference sizes with an annulus size ranging from 19 to 28 mm, the Allegra delivery system, and the Allegra loading system.
The Allegra THV is composed of a self-expandable stent frame with radiopaque gold markers and bovine pericardium. Per the company’s announcement, this stent frame design allows for pole movement that may be better for long-term durability.
Three valve sizes, 23, 27, and 31 mm, are commercially available in Europe. Each valve can be delivered via a flexible, low-profile, 18-F transfemoral delivery system with an integrated sheath for a stable implantation.
NVT also notes that the Allegra TAVR system may reduce procedural risk by eliminating the need for rapid pacing during deployment, which is common with other valves and can compromise hemodynamic stability during deployment and positioning.
The Allegra TAVR system is not available for use in the United States.