2025Year8Month4Boston Scientific Corporation Announces Its New Generation Left Atrial Appendage Closure SystemWATCHMAN FLX ProOfficially approved by the China National Medical Products Administration (NMPA) Approval,Becoming the first approved in China with polyvinylidene fluoride-Hexafluoropropylene (PVDF-HFP) Functional coating for left atrial appendage closure devices.This product is suitable for non-valvular atrial fibrillation (NVAF) and have a high risk of stroke, providing an innovative alternative to traditional oral anticoagulation therapy.

AsWATCHMANThird-generation product in the series,FLX ProContinues the full-recovery design advantage of the previous generation product and introduces for the first timePVDF-HFPCoating Technology. This coating, by regulating protein adsorption and cell adhesion behavior, can accelerate the endothelialization process on the surface of medical devices. Preclinical research data shows that the coating reduces the time for endothelial coverage to as early as post-operation.45Days (shortened compared to the previous generation)30%), while improving intraoperative positioning accuracy through visual marker design, with its size matrix expanded to24mm-35mmRange, covering patients with a wider range of anatomical variations.

For atrial fibrillation patients who need to take anticoagulant drugs for a long term,FLX ProProvides a new option for avoiding bleeding risks. Professor Zhang Shu, Director of the Arrhythmia Center at Fuwai Hospital, Chinese Academy of Medical Sciences, pointed out:"The Application Rate of Left Atrial Appendage Occlusion in China is Insufficient5%, mainly limited by the limitations of device indications and operational complexity. The controllable healing properties of the new coating can reduce device-related thrombosis (DRT) Incidence rate, while the extended size range will allow approximately15%Patients with special anatomical structures have access to treatment opportunities."

According to Boston Scientific2024Annual report, its structural heart disease business global revenue reached23.7billion dollars, of which the left atrial appendage closure product line contributed over40%. This timeFLX ProThe approval in China marks the company's transformation from technology introduction to local R&D – the Shanghai R&D Center participated in the adaptive improvement of the coating process. Industry analysts believe that, withDRG/DIPAs payment reform advances, innovative devices with clear health economics value will accelerate the replacement of traditional treatment solutions.

The approval of this product highlights the core role of biomaterials engineering in cardiovascular device innovation.PVDF-HFPAs a modified material that has been widely used in the cardiovascular implantation and intervention field, this functional breakthrough achieved through surface modification technology provides a technical paradigm for other areas such as absorbable stents and valve anti-calcification treatments. Zhang Jun, President of Boston Scientific Greater China, stated:"From metal stents to bioresorbable materials, and the application of functional coatings, advancements in material science are redefining the possibilities for interventional therapies."

This approval marks a new phase of precision and personalized treatment in China's structural heart disease intervention. With the advancement of medical insurance access negotiations, this product is expected to...2026The first quarter of the year achieved clinical application, for more than100New Treatment Option for High-Risk Patients with Non-Valvular Atrial Fibrillation.