China's First Anchoring Balloon Dilation Catheter Approved, Enhancing Success Rates in Cardiac Interventions

Economic Daily-China Economic Net, January 14 (Reporter Han Lu): Recently, the National Medical Products Administration announced the approval of an innovative medical device named “Anchoring Balloon Dilatation Catheter.” This catheter is the first in China to employ a balloon anchoring technique for catheter exchange, addressing challenges such as difficult microcatheter withdrawal, guidewire displacement, or even unintended guidewire exit from the lesion during percutaneous coronary angioplasty.

This “anchoring balloon dilation catheter,” manufactured by APT Medical Inc. (Hunan), is intended for interventional treatment of coronary artery stenosis caused by conditions such as coronary atherosclerosis. The product features a single-lumen delivery shaft design without a guidewire lumen, with the balloon directly attached to the catheter body, enabling deployment independent of a guidewire. Additionally, the stainless-steel catheter shaft incorporates a helical transition structure at its distal end, which is expected to provide superior pushability and reduce the risk of damaging the guiding catheter during advancement. Furthermore, the product’s structural design achieves a smaller outer crossing profile, which is anticipated to enhance compatibility with various commercially available guiding catheters and microcatheters.

Compared with current clinical practices, this product is expected to reduce vascular complications, shorten operative time, and improve surgical success rates.

The National Medical Products Administration stated that drug regulatory authorities will continue to prioritize clinical needs and accelerate the approval of medical devices urgently needed for clinical use. Meanwhile, post-market surveillance of marketed products will be strengthened to safeguard patient safety in device usage.