Boston Scientific Launches Athletis Peripheral High-Pressure Balloon Dilatation Catheter in China to Safeguard Hemodialysis Patients' 'Lifeline'

HangzhouMarch 25, 2022PR Newswire -- Recently, Boston Scientific (NYSE: BSX), a global leading medical technology company, officially announced the launch of its product Athletis Peripheral Balloon Dilatation Catheter in mainland China at the "Case Seminar on Combating Stubborn Vascular Lesions." The product is used for Percutaneous Transluminal Angioplasty (PTA) in peripheral vascular systems and for treating stenotic lesions in autologous or artificial arteriovenous dialysis accesses. It can also be applied for post-dilation of stents and covered stents within the peripheral vascular system. Compared to existing PTA balloons, Athletis, with an ultra-high pressure of up to 40ATM and excellent pushability, efficiently handles various types of common lesions in vascular access, safeguarding the "lifeline" of dialysis patients.

Launch Ceremony of Athletis Peripheral Balloon Dilation Catheter in Mainland China

Due to the scarcity of kidney sources, renal replacement therapy has long been recognized as the last hope for end-stage renal disease patients to sustain life, with 90% of patients undergoing hemodialysis treatment (hereinafter referred to as hemodialysis).^[1]In clinical practice, good vascular access is the "lifeline" for hemodialysis patients. However, due to the frequent occurrence of vascular access stenosis, the quality of life for patients significantly decreases. Studies have shown that autologous arteriovenous fistulas, a common form of vascular access, have a two-year patency rate of 65%, while the four-year patency rate is only 48%. Moreover, the one-year patency rate for prosthetic vascular grafts is as low as 36% to 42%.^[2]Stenosis of the internal fistula is a major cause of increased hospitalization and mortality rates in dialysis patients. Therefore, the maintenance of vascular access has become an important aspect in safeguarding the lifeline of dialysis patients.

Percutaneous Transluminal Angioplasty (PTA), a routine clinical solution for vascular access stenosis, is widely applied in China. The high-pressure balloon is the core device in PTA treatment. Studies show that, compared with ordinary balloons, high-pressure non-compliant balloons can achieve better lumens and maintain longer-lasting blood flow due to their high burst pressure and non-compliance, making them the preferred choice for hemodialysis access maintenance procedures.^[3]However, based on the expansion of high-pressure non-compliant balloons, there are still cases of refractory stenosis that cannot be fully dilated. Therefore, ultra-high-pressure balloons have emerged.

Boston Scientific Athletis Peripheral Balloon Dilatation Catheter Imported Medical Device Registration Certificate No. 20233030010

Boston Scientific's newly launched Athletis Peripheral Balloon Dilatation Catheter, as a non-compliant balloon, adopts a patented braided balloon design technology, enabling it to provide an ultra-high pressure of up to 40ATM.^[4], with both anti-scratch and anti-puncture properties, it can reach its nominal diameter even when dealing with high-resistance lesions. At the same time, it has a leading 0.042" distal tip crossing profile among similar products.^[5], combined with the smooth transition design from the tip to the shaft, also gives it the ability to efficiently cross severely narrowed lesions while minimizing the force required to pass through the lesion, ensuring that the surgery is performed efficiently while reducing damage to the lesion; the innovative design of the balloon and push rod also allows it to maintain ideal trackability in tortuous vessel environments, assisting operators in handling more complex lesions.

With its advantages such as ultra-high burst pressure of the balloon, low profile at the tip, and superior flexibility, this product is capable of addressing various common types of lesions found in vascular access, including highly calcified, long-segment, stenotic, or tough fibrous lesions, undoubtedly offering a more ideal option for clinical use.

Professor Jin Qizhuang, Chief Physician of the Department of Nephrology, Peking University First Hospital

Participants of this seminarProfessor Jin Qizhuang, Chief Physician of the Department of Nephrology, Peking University First Hospital"The maintenance of hemodialysis access has always been a very important issue clinically. We refer to this as the 'lifeline' for hemodialysis patients. The PTA procedure, as the preferred solution for handling access stenosis, has become relatively mature in China, but there are still many challenges. Therefore, we are very pleased to see the introduction of Boston Scientific’s ultra-high-pressure balloon into China. This is of great significance for upgrading treatment methods to address refractory stenotic lesions and will benefit hundreds of thousands of hemodialysis patients in China."

Speech by Dave Davis, Vice President of Boston Scientific China

Mr. Da Bo, Vice President of Boston Scientific China, stated: "Currently, in the Chinese market, Boston Scientific offers the most comprehensive interventional treatment solutions for peripheral vascular diseases in the industry. The newly introduced Athletis Peripheral Balloon Dilatation Catheter will be a strong addition to our hemodialysis access product line. Especially against the backdrop of the increasing prevalence of chronic kidney disease in China, we believe that this new product will quickly make its way into clinical use, providing better protection for the ‘lifeline’ of patients undergoing hemodialysis."

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 development of the global medical technology industry by providing a wide range of high-performance medical solutions that meet critical treatment needs of many patients and reduce healthcare costs.

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 Taipei. The company's core businesses cover cardiac intervention, structural heart disease, cardiac rhythm management and electrophysiology, endoscopic intervention, peripheral and tumor intervention, urology, respiratory products, and more. 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 provides high-quality medical products and services for prevention, diagnosis, and treatment. For more detailed information, please visit the company’s website: www.bostonscientific.cn

[1] Ji Daxi. Hemodialysis. Li Leishi, Liu Zhihong. Chinese Nephrology. Volume II. Beijing: People's Military Medical Press, 2008:1467-1470.

[2] Hu Daijun, Yin Lianghong. Pathological Changes and Prevention of Arteriovenous Fistula Stenosis[J]. Guangdong Medical Journal, 2013, 34(20): 3202-3204. DOI: 10.13820/j.cnki.gdyx.2013.20.023.

[3] Wang Geng, Chen Zhiqiang, Li Xiaohu, et al. Prospective analysis of high-pressure balloon versus conventional balloon in treating stenosis of autologous arteriovenous fistula [J]. Chinese Journal of Vascular Surgery (Electronic Edition), 2016, 8: 53-56.

[4] All products 8 mm balloons. Average measurements taken by Boston Scientific (n = 15). Data on file (TR 92200478). Bench test results may not necessarily by indicative of clinical performance

[5] Measurements taken by Boston Scientific, N =10, 8mm x 40mm product.  Data on file and available upon request