Shanghai, China - MicroPort Sorin CRM (Shanghai) Co ("MSC") recently completed the first implantation in the First-in-Man ("FIM") Clinical Trial of its in-house developed BonaFire® Pacing Leads ("BonaFire®") in Zhongshan Hospital of Fudan University. The operation achieved successful outcome, representing another solid step forward for MSC to further revolutionize China's pacemaker industry.
The FIM Clinical Trial of BonaFire® attracted wide attention from domestic cardiovascular professionals. According to Professor Yangang Su of Zhongshan Hospital, and Shengmei Qin, the surgeon who implanted the first BonaFire® in the clinical trial, the parameter and performance of BonaFire® are as good as the imported devices commonly used in clinic, with better structural design in some part. "So we are confident in its safety and long-term stability," they said. Professor Jialiang Mao of Renji Hospital Shanghai Jiaotong University School of Medicine, who participated in the early animal experiment of BonaFire®, noted: "We found no difference in leads handling between BonaFire® and imported pacing leads. Thus I believe most doctors would feel comfortable to use it after its official launch."
The R&D of BonaFire® is supported by the R&D funds of Science and Technology Commission of Shanghai Municipality, and Zhongshan Hospital and Renji Hospital participated in the whole R&D process of the product. In this sense, Professor Junbo Ge, the academician of Chinese Academy of Sciences and Director of Department of Cardiology of Zhongshan Hospital and Professor Ben He, Director of Department of Cardiology of Renji Hospital recognized BonaFire® as another successful case of clinical professionals participating in the R&D of medical devices, and pointed out that this is the path of success that domestic players should follow in developing high-end medical devices. Professionals from Chinese Society of Cardioelectrophysiology and Pacing of Chinese Medical Association as well as Heart Rhythm Society of Chinese Medical Doctor Association expressed their high expectations in the R&D of domestic pacemakers and related products.
Implanting pacemaker is the only effective therapy in treating bradycardia, widely used in developed nations. The pacing lead is an important component of the pacemaker system, implanted in atrium and ventricle to pace and sense with the pacemaker. "Once implanted, the pacing lead swings as the heart beats, normally at least 60 times per minute. And a qualified pacing lead should be working throughout the life span of two pacemakers, which is 10 years on average for each. This would demand the pacing lead to remain in good condition after swinging 600 million times," said Dr. Li Wang, Chief Executive Officer of MSC. This is undoubtedly a high requirement for the production technology of a pacing lead.
Currently, China basically relies on imports for pacing leads. As one of the few domestically developed pacing lead, BonaFire® has independent intellectual property right. It is so far the thinnest pacing lead in China, largely reduces the damage to blood vessels, and its design conforms to international standards, produced by advanced technology in the industry. The device can be mass produced with the support of China's first world-class cardiac pacemaker production line.
MSC will carry out multi-center clinical trials for BonaFire® to verify its electrical and mechanical performances as well as its safety and efficacy, which is estimated to be completed in two or three years. "The pacemaker has been selected as the Key High-performance Medical Device in China's 13th Five-Year Plan, which is a driving force behind MSC's R&D and innovations," said Dr. Li Wang. "We are constantly striving for excellence in terms of structure design, material selection and manufacturing technique of our pacing leads. We hope BonaFire® could soon be launched in China, to provide local patients with pacing leads of world-class quality and affordable price."
MSC is a joint venture formed in 2014 by Shanghai MicroPort Medical (Group) Co ("MicroPort®") and Sorin Group to market and develop cardiac rhythm management ("CRM") devices (implantable pacemakers, defibrillators, cardiac resynchronization devices and related devices) in China. Since 2010 MicroPort® has carried out large R&D investments in implantable pacemakers. On 27 June 2015, China's first domestic cardiac pacemaker production line with international advanced standards was launched in the company, to change China's pacemaker industry from "Made-in-China" to "Innovated-in-China."