On June 24, 2021, the TaurusElite® Transcatheter Aortic Valve Replacement System, the second-generation retrievable TAVR product independently developed by Peijia Medical Technology (Suzhou) Co., Ltd., was officially approved for marketing by National Medical Products Administration (NMPA) with the registration certificate number GXZZ 20213130464.
TaurusElite® Transcatheter Aortic Valve Replacement System consists of a prosthesis aortic valve (PAV), a retrievable delivery catheter system (DCS), and a loading system (LS). The PAV consists of bovine pericardial leaflets, a nitinol frame, and a sealing skirt to prevent paravalvular leakage. There are four models/specifications to fit aortic annulus with diameters ranging from 18 mm to 29 mm. The delivery catheter has a maximum outer diameter of up to 19F/20F, with in-line sheath models available.
TaurusElite® is a retrievable TAVR system that allows multiple retrievals during procedure.
TaurusElite® Transcatheter Aortic Valve Replacement System is indicated for patients suffering from severe calcified aortic stenosis who, as evaluated by a heart team, require aortic valve replacement but are not suitable for conventional valve replacement surgery.
Medical device name: TaurusElite® Transcatheter Aortic Valve Replacement System
Medical device manufacturer: Peijia Medical Technology (Suzhou) Co., Ltd.
Medical device registration certificate No.: GXZZ 20213130464