Hanchor Valve TAVR System Receives NMPA Innovative Product Approval — China’s Milestone for Pure Aortic Regurgitation Treatment

On June 24, 2026, China’s National Medical Products Administration (NMPA) granted formal regulatory approval to Shanghai Hanlin Medical Device Co., Ltd., a subsidiary of INT Medical, for its Hanchor Valve Transcatheter Aortic Valve System as an innovative medical device — marking a significant milestone in the treatment of pure severe aortic regurgitation (AR) in China.

The Clinical Challenge: Pure Aortic Regurgitation

Pure severe aortic regurgitation represents one of the most challenging subsets in the transcatheter aortic valve replacement (TAVR) landscape. Unlike aortic stenosis, where calcified native leaflets provide an anchoring framework for the implanted valve, pure AR patients have native leaflets without calcification support. This absence of calcium anchoring points makes traditional TAVR devices prone to valve migration, paravalvular leakage, and conduction disturbances — complications that have long been recognized as global treatment dilemmas in structural heart disease.

Three Core Innovations

The Hanchor Valve system addresses these challenges through three integrated design innovations under the philosophy of  Ball-Expand Innovation, Secure Anchoring Assurance:

1. Cobalt-Chromium Alloy Ball-Expandable Stent with Bovine Pericardium Leaflets

The valve adopts a cobalt-chromium alloy one-piece ball-expandable stent paired with bovine pericardium valve leaflets, following the widely familiar ball-expandable operating logic that clinicians are accustomed to. The release process is single-step controllable, significantly shortening the operator’s learning curve. The stent provides uniform and controllable radial support force, and is available in 23mm, 26mm, and 29mm sizes to cover mainstream AR patient anatomy.

2. Positioning Key Structure — Native Leaflet Clamping Anti-Migration Mechanism

The product’s Secure Anchoring capability is supported by a self-developed valve positioning key function. After valve deployment, the stent and positioning keys effectively clamp the patient’s native aortic valve leaflets, forming an anchoring mechanism that secures the valve without requiring calcification as an anchoring point — fundamentally reducing the risk of valve migration.

3. Adjustable-Bend, Recoverable Delivery System

The delivery catheter incorporates an adjustable-bend, recoverable manipulation structure, allowing flexible intraoperative adjustment of the delivery system’s head angle to achieve coaxial alignment between the aortic root and the device system. For complex procedures, the recovery function provides operators with an opportunity to correct initial positioning key placement.