Shanghai, China - MicroPort Sorin CRM (Shanghai) Co., Ltd. ("MSC"), a joint venture of Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®"), recently hosted center initiation meetings of the pre-market clinical trial for its in-house developed CompassAnalyzer™ Pacing System Analyzer ("CompassAnalyzer™ PSA") in three hospitals of Shanghai. 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. Up to date, several dozens of patients have been enrolled in the clinical trial.
The principal investigator of the CompassAnalyzer™ PSA clinical trial is Professor Yangang Su of Zhongshan Hospital of Fudan University, and other investigators include Professor Liqun Wu of Ruijin Hospital of Shanghai Jiao Tong University and Professor Ying Li of Shanghai East Hospital. 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, the PSA market is almost a blank market with urgent demand for portable and easy-to-use PSAs.
During the meeting, the investigators expressed their hope on the market launch of CompassAnalyzer™ PSA. Professor Yanggang Su said: "There has been no portable PSA in the market for a long period. We are looking forward to the launch of CompassAnalyzer™ PSA in the China market to meet such an urgent need." Professor Ying Li spoke highly of CompassAnalyzer™ PSA for its portable design and easy operation. "Once launched in China, CompassAnalyzer™ PSA will for sure facilitate physicians, especially those in regional hospitals, to perform pacemaker procedures," said Professor Li. MSC Chief Executive Officer Dr. Li Wang said: "It is expected that CompassAnalyzer™ PSA will fill the gap in China's PSA market, break the monopoly of imported devices and provide better solutions for physicians and patients."