On April 19, 2021, the TaurusOne® Transcatheter Aortic Valve Replacement System, a milestone product independently developed by Peijia Medical Technology (Suzhou) Co., Ltd., was officially approved for marketing by the National Medical Products Administration (NMPA) with the registration certificate number GXZZ 20213130275.
TaurusOne® Transcatheter Aortic Valve Replacement System consists of a prosthesis aortic valve (PAV), a 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 18F, compatible with 0.035in guidewires. It also has a radiopaque marker band at the distal end of the sheath. Before an operation, the prosthesis is gripped and loaded to the sheath through the loading system.
Medical device name: TaurusOne® Transcatheter Aortic Valve Replacement System
Medical device manufacturer: Peijia Medical Technology (Suzhou) Co., Ltd.
Medical device registration certificate No.: GXZZ 20213130275