Wushuang Medical Completes Multicenter Pivotal Clinical Enrollment for Implantable Cardioverter Defibrillator (ICD)

On December 19, 2023, Singular Medical initiated the first clinical enrollment for its implantable cardioverter defibrillator (ICD). By July 25, 2024, the 75th patient successfully completed enrollment in this clinical trial.

The 75 enrolled participants are broadly representative, covering both primary and secondary prevention of sudden cardiac death, with ages ranging from 21 to 83. Patients are from provinces and cities including Jiangsu, Anhui, Gansu, Sichuan, Yunnan, Guangdong, Shaanxi, and Shanghai.

All 75 patients successfully completed the intraoperative induction and defibrillation tests, with the ICD automatically identifying and delivering a shock to restore normal rhythm.Currently, 59 patients have completed the 30-day follow-up, 24 patients have completed the 90-day follow-up, and 6 patients have completed the 180-day follow-up.Outside the hospital, within the 8-month enrollment period, the Singular ICD successfully treated 3 cases of spontaneous VF, 4 cases of spontaneous VT, and differentiated 4 cases of SVT. The effectiveness and safety of the Singular ICD in real-world settings have been preliminarily validated, laying a solid foundation for clinical application.

Singular Medical demonstrated comprehensive attention to patient safety and adherence to the spirit of scientific research collaboration throughout this process.

Our sincere thanks to the experts and their teams at each center who collaborated on the clinical research:Professor Wei Xu from the Affiliated Drum Tower Hospital of Nanjing University Medical School, Professor Yangan Su from Zhongshan Hospital Affiliated to Fudan University, Professor Tingbo Jiang from the First Affiliated Hospital of Soochow University, Professor Yangxin Chen from Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Professor Bing Han from Xuzhou Central Hospital, Professor Ruxing Wang from Wuxi People's Hospital, Professor Xingbin Liu from West China Hospital of Sichuan University, Professor Xiaolin Xue from the First Affiliated Hospital of Xi'an Jiaotong University (in order of initiation).Their expertise and dedication are key to the success of the project. This close interdisciplinary and multi-center collaboration not only advances medical research but also promotes the optimal allocation and sharing of medical resources.

The innovation and development of medical technology is a long-term and arduous process, and every breakthrough and innovation is a sign of respect for life. We look forward to the wisdom and manufacturing in China contributing to the advancement of global health, building a brilliant殿堂 in the field of arrhythmia. Let the vast population suffering from sudden cardiac death find lasting peace of mind!

Company Profile:

Singular Medical is a hard-tech enterprise focused on the research, development, and industrialization of medical devices related to Cardiac Rhythm Management (CRM). The company's headquarters is located in the Suzhou High-Tech Zone Medical Device Park, with a 2,800-square-meter manufacturing plant, and offices in Beijing and Irvine, USA.MingThe state has established a research and development center. Singular Medical started with the most technically challenging product in the CRM field, the ICD, and has built a complete CRM technology platform. It is growing into a supplier of full-line products in China's CRM field, capable of providing arrhythmia patients with comprehensive solutions from monitoring, diagnosis, treatment to postoperative follow-up.