Peijia Medical's innovative TAVR system accepted for NMPA registration

Peijia Medical Limited announced today that its registration application for the TaurusNXT® Non-glutaraldehyde Crosslinked Dry-tissue Transcatheter Aortic Valve Replacement (TAVR) system has been accepted by China's National Medical Products Administration (NMPA). The innovative system has also been accepted under the Special Review and Approval Procedure for Innovative Medical Devices, indicating it will be prioritized for appraisal and approval.

The TaurusNXT® system, an internally developed third-generation TAVR, incorporates patented non-glutaraldehyde bio-tissue crosslinking technology aimed at improving durability and biocompatibility by addressing the primary cause of prosthetic valve calcification. It utilizes ultra-low temperature vacuum freeze-drying technology for pre-loading into the delivery catheter system, preserving valve tissue integrity.

The system's delivery catheter has been upgraded with both retrievability and steerability features, designed to enhance procedural safety and ease of implant guidance for physicians. This announcement provides an update on the group's new product development progress.