MSC CompassAnalyzer™ PSA Completes Patient Enrollment

Shanghai, China – MicroPort Sorin CRM (Shanghai) Co., Ltd. ("MSC"), a joint venture of Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort^®"), recently completed the patient enrollment for the clinical trial of its in-house developed CompassAnalyzer™ Pacing System Analyzer ("CompassAnalyzer™ PSA"). The clinical trial is the first pre-market multi-center clinical trial launched by MSC since the implementation of China's Quality Control Regulations of Clinical Trials for Medical Devices from June 1, 2016. Zhongshan Hospital of Shanghai Fudan University (principal investigator), Ruijin Hospital of Shanghai Jiao Tong University, and East Hospital of Shanghai Tongji University participated in the clinical trial and over 100 patients have been enrolled.

The pacing system analyzer ("PSA") is external equipment needed in pacemaker implantation for physicians to evaluate electrical parameters of pacemaker leads. In recent years, with the phase out of the imported products that used to monopolize the market, there has been no portable and easy-to-use PSA in the market for a long period. So, physicians are looking forward to the launch of the domestically made CompassAnalyzer™ PSA in the China market to meet such an urgent need. Once launched in China, CompassAnalyzer™ PSA will facilitate physicians, especially those in regional hospitals, to perform pacemaker procedures.

Since the establishment of MSC, it is devoted to developing and manufacturing innovative products uniquely designed for China's clinical needs. In the clinical trial of CompassAnalyzer™ PSA, MSC's R&D engineers had in-depth communication with clinicians to fully understand the clinical application and clinical needs of pacemaker treatment. MSC will continue to innovate and develop products based on China's clinical needs to offer more ideal solutions for Chinese patients.