(Registration Certificate No.: GXZZ20213130275)
On April 19, 2021, the TaurusOne® Transcatheter Aortic Valve System (Registration Certificate No.: GXZZ20213130275), the milestone product independently developed by Peijia Medical was officially approved for marketing by the National Medical Products Administration (NMPA).
TaurusOne® Transcatheter Aortic Valve System is comprised 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 leak. There are four models/specifications to fit aortic annulus with diameters ranging from 18 mm to 29 mm. The maximum outer diameter of the delivery catheter is 18F, which is compatible with 0.035in guidewire and 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.
TaurusOne® Transcatheter Aortic Valve System is indicated for patients suffering from severe calcified aortic stenosis who have been evaluated by a heart team as requiring aortic valve replacement but not suitable for conventional valve replacement surgery.
|Model/Specification of Bioprosthesis||Dimensions (mm)||Annulus Diameter (mm)|
|Model/Specification of Delivery System||Outer Diameter (F)||Effective Length (cm)|
The images shown are indicative only