Ningbo, China, 12 May 2021 —Subject enrollment for the pre-market clinical trial of the MicroPort® Contact Force-Sensing RF Ablation Catheter (“Contact Force-Sensing Catheter”), developed by Shanghai MicroPort EP MedTech Co., Ltd. ("MicroPort® EP"), has been completed. The final operation under the trial was performed by Huimin Chu’s team in the Department of Cardiovascular Medicine at Ningbo First Hospital on March 30th, using the Contact Force-Sensing Catheter in combination with the Columbus®️ 3D EP Navigation System.
The clinical trial of the Contact Force-Sensing Catheter is a prospective, multi-center clinical study designed to evaluate the safety and efficacy of the pressure monitoring function of the catheter, the tubing set and the 3D EP navigation system developed and manufactured by MicroPort® EP for atrial fibrillation clinical applications. The First Hospital of Dalian Medical University is leading the study in collaboration with the First Hospital of Ningbo, the First People’s Hospital of Shanghai, Shanghai Oriental Hospital, and Xuzhou Central Hospital.
Dr. Yiyong Sun, President of MicroPort® EP, said, “We were facing difficult challenges during the implementation of this clinical trial due to the impact of the COVID-19 pandemic. Therefore, we are very grateful for the strong support from hospitals involved in this study. The completion of subject enrollment is an important milestone in the clinical trial, and we look forward to receiving early results that are hopefully in line with our expectations.”
Chu Huimin, Director of the First Hospital of Ningbo, commented, “Although the EP industry in China started late, we are confident that MicroPort® EP is capable of developing and improving our portfolio of EP products while leading China’s EP industry to thrive in its own path.”
The Contact Force-Sensing Catheter used in this clinical trial provides surgeons with real-time force values of the catheter where it comes in contact with the inner wall of the cardiac cavity during atrial fibrillation ablation procedures. Compared with conventional 3D catheters, it can shorten procedure time, reduce complications, and X-ray damage to both the patient and the surgeon. The Catheter also helps to shorten the learning curve for newly trained surgeons.
Currently, this catheter has passed the special approval process of the NMPA for innovative medical devices and is expected to become the first domestic contact force-sensing catheter to be certified for marketing in China. In the future, MicroPort® EP will continue to invest more resources in innovative research and development, as well as clinical trials, to provide better integrated solutions for patients and doctors.
About atrial fibrillation
Atrial fibrillation (AF) is one of the most common cardiac arrhythmias, and can cause complications such as stroke and heart failure. Currently, radiofrequency (RF) ablation is the most effective treatment for AF due to its low invasiveness and fast recovery, but it has little selectivity in destroying tissues in the ablation area and the procedure depends on the contact force of the catheter. In clinical practice, there is an urgent need for a product such as the Contact Force-Sensing Catheter, which provides intraoperative information on catheter contact orientation and contact force level, facilitating the transmural ablation of lesions in a safer, more effective and continuous way, and improving the success rate of procedures.
About MicroPort® EP
Shanghai MicroPort EP MedTech Co., Ltd. (“MicroPort® EP”) is a subsidiary of Shanghai MicroPort Medical (Group) Co., Ltd. (“MicroPort®”, stock code: 00853.HK). MicroPort® EP's product portfolio aims to provide doctors and patients with systematic integrated solution to electrophysiological interventional procedures, which has allowed the company to make high precision electrophysiology product more accessible for patients across the globe.