(Registration Certificate No.: GXZZ20213130464)
On June 24, 2021, the TaurusElite® Transcatheter Aortic Valve System (Registration Certificate No.: GXZZ20213130464), the second-generation TAVR product which is retrievable, independently developed by Peijia Medical was officially approved for marketing by the National Medical Products Administration (NMPA).
TaurusElite® 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 19F/20F and in-line sheath models are available.
TaurusElite® is a retrievable TAVR system that allows for multiple times of intraoperative recycling.
TaurusElite® 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