Suzhou AccuMed Pulse PFA System Completes Clinical Enrollment with 100% Acute Success Rate

Pulsed Field Ablation (PFA) technology is regarded as the most prominent innovation track in the field of electrophysiology in recent years. This disruptive ablation technique is being validated concurrently both domestically and internationally, with pulsed energy poised to become a superior clinical alternative following radiofrequency and cryoablation. Recently, Suzhou Accupulse Medical Technology Co., Ltd. successfully completed patient enrollment for its independently developed AccuPulse Pulsed Field Ablation System, placing it among the leading tier of PFA products undergoing clinical research both in China and abroad. The system is scheduled for market launch in 2025, alongside the company’s self-developed cardiac 3D mapping system.

This clinical study was led by Professor Jiang Chenyang of Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, as the Principal Investigator (PI), and was conducted jointly by multiple authoritative tertiary Grade A clinical research institutions across China. In this study, over 70% of subjects underwent the procedure under local anesthesia plus sedation, achieving a 100% immediate success rate. The average time to complete pulmonary vein isolation per procedure was 50 minutes, with an average total ablation time of only 30 seconds and an average fluoroscopy time of approximately 7 minutes. As of the press date, no device-related adverse events had occurred in the trial, and patients’ quality of life improved significantly postoperatively.

Furthermore, all investigators were able to successfully complete the inaugural procedure. There was no significant difference between the mean operative time in the early phase of the trial and that in the later phase, indicating that investigators could master the use of the AccuPulse Pulsed Ablation System through a short learning curve. The trial results fully demonstrate the safety and efficacy of the AccuPulse Pulsed Ablation System.

“Leveraging PFA energy for ablation holds promise for breaking through the bottlenecks in atrial fibrillation (AF) treatment. As China’s population ages, the number of AF patients is steadily increasing. Currently, approximately 100,000 patients receive treatment annually, while the target patient population numbers in the millions. To enable more AF patients to access high-quality care, there is a clinical need for disruptive therapeutic technologies and tools.” Professor Jiang pointed out that innovative technology is key to addressing current clinical challenges. The AccuPulse Pulsed Field Ablation System features catheter-tissue contact indication, helping physicians assess the contact status between the catheter tip and the target tissue. Its adjustable-diameter catheter tip design accommodates pulmonary veins of varying sizes. Furthermore, the system is compatible with currently used clinical 3D mapping systems, making AF ablation procedures faster, safer, and simpler!

Aikemai Medical is a startup focused on the research, development, and manufacturing of electrophysiology products. Established in November 2020, the company has set up R&D centers and offices in Suzhou, Shanghai, and the United States. In 2022, it was recognized by MedTech Outlook as one of the Top 20 Best Healthcare Technology Companies of the Year. Upholding the corporate culture of “Endless Innovation, Constant Renewal,” Aikemai Medical adopts a patient-centric approach, leveraging the strengths of its Sino-US R&D teams to provide comprehensive treatment solutions for patients with arrhythmias, thereby better serving the broad population of atrial fibrillation patients.