US-based medical technology major Boston Scientific Corporation (NYSE: BSX) has announced the initiation of the real-world REPLACE study for its pulsed field ablation (PFA) system, FARAPULSE, in Chinese patients with paroxysmal atrial fibrillation (PAF). The study is being conducted at the Boao Lecheng Medical Tourism Pilot Zone of Hainan Province, where FARAPULSE completed the first domestic “first pilot, first trial” surgery.
Background of FARAPULSE
The FARAPULSE PFA system has previously been granted a special review status by the Center for Medical Device Evaluation (CMDE). This recognition highlights the innovative nature of the technology and its potential to offer new treatment options for patients with atrial fibrillation.
Significance of the REPLACE Study
The REPLACE study aims to evaluate the effectiveness and safety of the FARAPULSE system in real-world clinical settings. This will provide valuable data to support the system’s application and further enhance its clinical profile, potentially benefiting a broader range of patients with paroxysmal atrial fibrillation in China and beyond.
Company’s Commitment
Boston Scientific’s initiation of the REPLACE study underscores its commitment to advancing medical technologies and improving patient outcomes. The company continues to innovate and expand its offerings in the field of cardiac rhythm management, ensuring that patients have access to the latest and most effective treatment options.-Fineline Info & Tech
