Subject Enrollment Completed for Pre-market Clinical Study of MSC’s BonaFire® Lead

Shanghai, China, 15 January 2022 — MicroPort Soaring CRM (Shanghai) Co., Ltd. (MSC) recently announced the enrollment of the final two patients for the pre-market clinical study of the BonaFire® MRI compatible lead (BonaFire® lead) at the Zhongshan Hospital of Fudan University and the Tongji Hospital affiliated to Tongji Medical School of Huazhong University of Science and Technology, respectively, marking the completion of subject enrollment for the study.

The clinical study is a nationwide, prospective, multicenter, randomized, parallel controlled study designed to validate the safety and efficacy of the implantable MRI-conditional pacing system for the treatment of bradyarrhythmias. In collaboration with 17 medical centers across China, Zhongshan Hospital of Fudan University took the lead in implementing the study under the leadership of the principal investigator Prof. Yangang Su from the hospital’s Department of Cardiology.

Pacing leads are an important component of the pacing system that stays with the patient for years. A reliable lead not only plays a role in the success of the implantation surgery, but also ensures the long-term function of the pacing system after the surgery. As a bipolar lead, BonaFire® lead not only offers stable sensing and pacing performance but also allows patients to safely undergo full-body MRI scans at 1.5T.

Prof. Yangang Su, the principal investigator of this clinical study, noted, “Pacing leads are a crucial component of the pacing system. Most patients who have pacemakers implanted for bradyarrhythmias may also suffer other underlying conditions. The MRI-conditional pacing lead can provide greater benefit for those who may need to undergo MRI examinations after the implantation. As seen in the implantation surgeries of the enrolled patients, the maneuverability and various parameters of the BonaFire® lead are comparable to those of imported leads. I believe that we will be able to complete the clinical follow-up and achieve the expected results. I also look forward to the launch of BonaFire® for the benefit of patients as soon as possible. ”

Mr. Xiaoming Zhu, General Manager of MSC, said, “With full adherence to international standards, the BonaFire® lead is developed using state-of-the-art mainstream technologies, such as the controlled steroid-eluting mechanism, titanium nitride coating, and silicone-rubber-insulated layer. We also strive for excellence in material selection, structural design, and manufacturing processes. The completion of subject enrollment marks a major step forward in bringing BonaFire® to market. We hope that BonaFire® will fill a market gap in China as soon as possible to help more patients with cardiac arrhythmia. At the same time, MSC will continue to address the clinical needs of Chinese patients and physicians by promoting localized technological development and manufacturing in the field of heart rhythm management for more inclusive and accessible total medical solutions for cardiac rhythm diseases.”

About MicroPort Soaring CRM (Shanghai) Co., Ltd
MicroPort Soaring CRM (Shanghai) Co., Ltd. (“MSC”), is a subsidiary of MicroPort® Scientific Corporation (00853.HK). As a developer and manufacturer of medical devices in the field of cardiac rhythm management, MSC has always committed itself to innovation and research, to provide premium CRM products and services to patients in China and around the world. In the future, MSC will continue to further understand the clinical needs of Chinese patients and physicians, and to develop more targeted and refined treatment and management solutions to patients with heart diseases.