CAPRI Clinical Investigation of ENO™/TEO™/OTO™ Pacing System by MicroPort® CRM Completes First Enrollment of Chinese Patients

Zhejiang, China, 22 June 2021 — Recently, the “Clinical Investigation of ENO/TEO/OTO Pacing System (CAPRI)”, successfully completed the clinical enrollment of the first six patients at the Second Affiliated Hospital of Zhejiang University School of Medicine, marking the official launch of this global multicenter clinical study in China. The study, initiated by MicroPort® CRM and conducted by MicroPort Soaring CRM (Shanghai) Co., Ltd. (MSC), aims to further evaluate the safety and efficacy of the ENO™/TEO™/OTO™ Pacing System when used under 1.5T or 3.0T specific Magnetic Resonance Imaging (MRI) conditions by collecting relevant clinical evidence.

Of the six patients to receive pacemaker implantation as part of the study, five were over 50 years old and oldest was 83. The program plans to enroll 270 patients at 29 clinical centers in Europe, Australia and China with an approximately one-year follow-up. Prof. Meixiang Xiang of the Second Affiliated Hospital of Zhejiang University School of Medicine serves as the principal investigator of the study in China, and Dr. Dennis Lau of the Royal Adelaide Hospital in Australia is the Coordinating Investigator, responsible for coordinating the study across clinical centers.

As the principal investigator of the CAPRI study in China, Prof. Xiang commented that MRI-compatible pacing systems are a major trend of pacing therapy and have been widely used in clinical practice at the Second Affiliated Hospital of Zhejiang University. She said, “Patients implanted with MRI-compatible pacing systems will no longer be barred from MRI examinations, allowing them to undergo proper diagnosis and treatment for other diseases. This study will provide the necessary clinical data for the registration and marketing of the product in China. We hope that more MRI-compatible pacing systems will be available for clinical use in the future. We especially look forward to the development and manufacturing of domestic MRI-compatible pacing systems to benefit more patients in China.”

In January 2019, MicroPort® CRM announced the approval of its next-generation transvenous pacemaker system, which includes pacemaker families ENO™, TEO™ and OTO™ and the Vega pacing leads, for marketing in Europe. All three models are compatible with 1.5T/3T whole-body MRI scanning and feature advanced AutoMRI™ technology. This not only allows it to automatically turn on MRI mode upon detecting the magnetic field of the MRI device, ensuring patient safety, but also can restore the original pacing parameter settings after the patient leaves the MRI environment upon completion of the scan.

Jack Zhu, General Manager of MSC, said, “MicroPort® CRM seeks to provide a total solution for patients with arrhythmias. The three pacemaker families of ENO™, TEO™ and OTO™ and the Vega pacing leads minimize unnecessary medical interventions before and after MRI examinations for patients with an implanted pacemaker, while reducing the burden on clinicians and ensuring optimal patient care. We hope that the CAPRI clinical study could lay the groundwork for the early approval of these products by the National Medical Products Administration (NMPA) of China, and provide clinicians and patients with a total solution for heart rhythm management.”

About MicroPort® CRM

MicroPort® CRM, a subsidiary of MicroPort Scientific Corporation (00853.HK), is a pioneering company in the field of cardiac rhythm management (CRM), whose world headquarters are in Clamart, near Paris, France. Through our long-standing expertise in CRM, MicroPort® CRM develops, manufactures and markets cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems, and ECG diagnostic solutions for the management of cardiac rhythm disorders and heart failure around the world.

About MicroPort Soaring CRM (Shanghai) Co., Ltd.

MicroPort Soaring CRM (Shanghai) Co., Ltd. (MSC) is a subsidiary of MicroPort Scientific Corporation (00853.HK). MSC is a developer and manufacturer of medical devices in the field of cardiac rhythm management (CRM). MSC has always committed itself to the development philosophy of “Created in China” and “Made in China” to provide premium CRM products and services to patients. In the future, MSC will continue to meet the clinical needs of patients and doctors in China and offer more targeted and refined cardiology treatment and management solutions.