Boston Scientific Completes First "Pilot Trial" Procedure in China with RotaPro Rotational Atherectomy System at Ruijin Hospital Hainan

BoaoSeptember 23, 2022PR Newswire -- Today, Boston Scientific Corporation (NYSE: BSX) successfully completed the first "Pilot Trial" surgery in China using the RotaPro Rotational Atherectomy System* at Hainan Hospital of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (Boao Research Hospital). This surgery marks the product's first clinical application prior to its official launch in China and represents the first "Pilot Trial" exploration in China’s coronary interventional device field, potentially accelerating the introduction of more cutting-edge technologies in minimally invasive interventions into China.

Coronary Artery Plaque Rotablation is Clinically Recognized as the Preferred Treatment for Severe Calcified Lesions in Coronary Heart Disease, but Due to Its Relatively Complex Surgical Operation and High Requirements for Surgeons, It Has Been Difficult to Be Widely Adopted in Clinical Practice. Boston Scientific's RotaPro Product, by Greatly Simplifying the Operation of Coronary Artery Plaque Rotablation and Improving Surgical Efficiency, Significantly Reduces the Learning Curve for Doctors, Making It an Ideal Solution to Overcome the Challenges of Applying Rotablation Surgery.

First Case Launch Ceremony of RotaPro Rotational Atherectomy System "Pilot Trial"

Classic products pioneer the rotational atherectomy procedure, new products further assist.PCI Quality Improvement and Efficiency Enhancement

Calcified lesions are one of the common characteristic pathological manifestations of coronary heart disease. Due to their hard texture and the difficulty in handling with conventional instruments, they represent one of the biggest challenges in percutaneous coronary intervention (PCI) procedures. To address the treatment difficulties posed by coronary artery calcified lesions, Boston Scientific introduced the Rotablator to China in 1995, pioneering the application of coronary plaque rotational atherectomy in China. This product remains a mainstay in Chinese clinical practice to this day.OnlyThe recognized rotational atherectomy system has been used in tens of thousands of PCI procedures, and its reliability has been unanimously acknowledged.

RotaPro Rotational Atherectomy System

The RotaPro System applied in this surgery was designed and developed by a Chinese R&D team. It not only inherits the mature system and extensive clinical application experience of its predecessor but also achieves breakthroughs in the lightweight and intelligent aspects of the rotational atherectomy system. For instance: The integrated propulsion controller simplifies surgical steps by controlling the rotation of the burr,告别了以往“手脚并用”的复杂操作，allowing doctors to quickly grasp the essentials of rotational atherectomy; it is equipped with a brand-new intelligent control system that can display the rotational speed in real time, facilitating doctors' learning and standardizing operational techniques. Additionally, the product's size has been reduced to handheld level, making it portable in a backpack, convenient for doctors to teach outside at any time. The innovatively designed RotaGO integrated platform pre-installs all device components and significantly reduces the equipment size, enabling flexible transportation between multiple catheterization labs within the hospital, greatly improving the efficiency of the catheterization lab.

As the "chief surgeon" of this operation, Zhang Ruiyan, Director of the Cardiology Department at Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine, stated: "China currently has 13.39 million patients with coronary heart disease, and more than a million PCI treatments are performed each year."^[1], while the incidence of coronary artery calcification in the population aged 60-69 is as high as 80%.^[2]"As the aging population deepens, the challenge of calcified lesions will become even more severe. However, the RotaPro makes rotational atherectomy more convenient, easier to use, and more efficient, offering more doctors in China, especially those in grassroots hospitals, the opportunity to master this technique. This undoubtedly helps promote the widespread application of rotational atherectomy and reduce the treatment burden of coronary artery calcified lesions in China. I am very much looking forward to the launch of this product."

Zhang Ruiyan, Director of the Department of Cardiology at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Leveraging the fertile ground of Lecheng to forge strong alliances and create the latest global technologies"First Use" Platform

As the effective implementation of institutional integration and innovation, the industrial agglomeration effect in Boao Lecheng has become prominent, attracting numerous well-known medical institutions such as Ruijin, Huaxi, and Shanghai Jiao Tong University School of Medicine, as well as an increasing number of internationally leading enterprises in recent years. It has now become fertile ground for the fusion and co-creation of "industry, academia, research, and medicine." At the启动仪式 of the surgery on the same day, Ning Guang, President of Ruijin Hospital at Shanghai Jiao Tong University and academician of the Chinese Academy of Engineering, emphasized in his speech: "The successful application of the RotaPro™ Rotational Atherectomy System is expected to accelerate the introduction of more cutting-edge technologies in the field of minimally invasive interventions into China. Ruijin Hainan Hospital will also take this opportunity to focus on inter-hospital cooperation by being the pioneer in utilizing this internationally advanced permitted device. This aims to expedite the strategic goal of ensuring that people in Hainan can receive treatment for serious illnesses without leaving the island and help the people of China receive treatment for major diseases without going abroad."

Fu Zhu, member of the Party Committee and Deputy Director of the Lecheng Administration, stated that Shanghai Ruijin Hospital is fully playing the role of "vanguard," leading the development of the healthcare industry in the Lecheng Pilot Zone and supporting the construction of the Hainan Free Trade Port. It is believed that with the strong support of the Hainan Provincial Party Committee and Government, the close collaboration of various relevant departments, and the leadership of Ruijin Hainan Hospital, more public hospitals and renowned experts in China will gradually cooperate with Lecheng, bringing about significant development for Lecheng. It is hoped that in the future, Ruijin Hainan Hospital will make full use of its own advantages, leverage the preferential policies of the Hainan Free Trade Port and the Lecheng Pilot Zone, partner with more outstanding medical institutions and enterprises, gather innovative elements and resources in medical science and technology, create more medical precedents, and benefit patients both domestically and internationally.

At the end of December last year,Boston Scientific and Hainan Hospital of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (Boao Research Hospital) have reached a cooperation intention to jointly build the "Innovative Medical Technology Practice Base." The aim is to leverage the favorable policies of Lecheng to create a platform for the first use in China of the latest global medical technologies in the interventional field. The RotaPro system applied in this surgery is the first product to be implemented at this base. "In the future, Ruijin Hainan Hospital will further cooperate with Boston Scientific to jointly accelerate the introduction of global innovative technologies in the cardiac intervention field into Chinese clinical practice, contributing to the new heights of clinical application of new technologies, products, and drugs in the Lecheng Pilot Zone," said Gu Zhi Dong, Dean of Ruijin Hospital Hainan.

Ms. Zhang Jun, President of Boston Scientific Greater China Region

Ms. Zhang Jun, President of Boston Scientific Greater China, stated: "RotaPro is already the third product from Boston Scientific to enter clinical use in Lecheng. Thanks to the high level of openness and the platform advantages in Lecheng, Boston Scientific has been able to partner with Ruijin Hospital Hainan Hospital and successfully carry out this 'pilot' collaboration, which has injected new momentum into our 2.0 era in Lecheng. We look forward to continuing to work hand-in-hand with top-tier partners from all sectors to write new stories of innovation and cooperation in Lecheng, jointly shaping a future where accessible healthcare is within everyone's reach in China."

*This product has not yet been launched in mainland China.

[1] National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences. "Report on Cardiovascular Health and Diseases in China 2021". Chinese Journal of Circulation. June 2022.

[2] Wang Weimin, Huo Yong, Ge Junbo "Chinese Expert Consensus on the Diagnosis and Treatment of Coronary Artery Calcification Lesions (2021 Edition)". Chinese Journal of Interventional Cardiology, 2021, 29(5): 251-259

About Boston Scientific

Boston Scientific Corporation is committed to innovation for life. We are dedicated to innovative medical solutions that improve the lives of patients worldwide. For over four decades, Boston Scientific has consistently led the global medical technology industry by delivering a wide range of high-performance medical solutions to meet the urgent healing needs of patients and reduce healthcare costs. For more detailed information, please visit the company website:www.bostonscientific.cn 

About Boston Scientific Greater China

Boston Scientific established its China headquarters in Shanghai in 1997 and currently has branch offices in Beijing, Guangzhou, Chengdu, Hong Kong, and Taiwan. Its core businesses in China include interventional cardiology, structural heart disease, cardiac rhythm management and electrophysiology, peripheral interventions, oncology interventions, endoscopy interventions, respiratory interventions, urology and pelvic health, ENT, and neuromodulation. Upholding its tradition as an innovation leader, Boston Scientific is committed to becoming a respected medical technology company that meets the needs of doctors and patients, demonstrates innovative vitality, and delivers high-quality medical products and services for prevention, diagnosis, and treatment. For more detailed information, please visit the company website:www.bostonscientific.cn