Ningbo-based structural heart disease device manufacturer Jenscare Scientific Co., Ltd (HKG: 9877) has announced that its in-house developed transcatheter tricuspid valve replacement system product has been included in the Total Product Life Cycle Advisory Program (TAP) of the US FDA. The program’s objective is to ensure that US patients have early access to high-quality, safe, effective, and innovative medical devices by fostering early, frequent, and strategic communication between the FDA and medical device sponsors.
The Significance of FDA’s TAP Program
As of September this year, a total of 9 medical devices have been admitted into the FDA’s pilot scheme, which is designed to provide a framework for the development and approval of cutting-edge medical technologies. Participation in the TAP program is a significant milestone for Jenscare Scientific, as it indicates that the company’s tricuspid valve replacement system is recognized for its potential to offer a novel solution in the treatment of structural heart diseases.
Enhancing Patient Access to Innovative Medical Devices
The FDA’s TAP program is instrumental in accelerating the availability of innovative medical devices in the US market. By including Jenscare Scientific’s transcatheter tricuspid valve replacement system, the FDA is prioritizing the advancement of therapies that can improve patient outcomes and contribute to the evolution of cardiac care.-Fineline Info & Tech
