Ryflumen®, First Peripheral High-Pressure Balloon Dilatation Catheter of Endovastec™, Approved for Marketing by NMPA

Shanghai, China, 16 November 2021 — Shanghai VasoLutions MedTech Co. Ltd. (VasoLutions™), a wholly-owned subsidiary of Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (Endovastec™) recently received a marketing registration certificate issued by the National Medical Products Administration (NMPA) for its Ryflumen® Peripheral High-Pressure Balloon Dilatation Catheter.

Ryflumen® is a high-pressure balloon dilatation catheter for peripheral intervention, which is indicated for percutaneous transluminal angioplasty (PTA). PTA is a primary procedure for treating peripheral vascular disease. It requires a balloon catheter with high dilatation pressure, low compliance, excellent crossability, pushability, and trackability, and short deflation time to achieve effective dilatation of the lesion area, as well as shortened operation time.

Ryflumen® provides higher dilatation pressures (up to 24 atm) than conventional balloon dilatation catheters, allowing for more effective dilatation of stenotic lesions. It also features a lower compliance rate, which can effectively reduce the incidence of vascular dissection. In addition, it is available in a wide range of balloon specifications (diameters from 3.0 to 14.0 mm, lengths from 20 to 220 mm), and four catheter lengths (40, 75, 135, and 150 cm) to meet various clinical needs. The unique one-piece tip configuration of Ryflumen® facilitates increased balloon catheter ability to access.

The push rod is a coextrusion of multiple materials for rigidity and flexibility, while the balloon and catheter are coated with a hydrophilic coating that significantly improves pushability, flexibility, and tracking. The dual-lumen design of the push rod, coupled with optimized catheter welding and assembly design, ensures industry-leading performance in terms of balloon deflation time. The double-layered balloon design achieves high inflation pressure while effectively reducing the balloon wall thickness, enhancing the folding memory of the balloon and improving sheathing and unsheathing performance.

Dr. Lantao Guo, General Manager of VasoLutions™, stated, “We have been devoting ourselves to the field of peripheral vascular devices and rapidly improving our portfolio strategy. Currently, we have three peripheral arterial products including the Reewarm® PTX Drug-Coated Balloon Catheter. As the first high-pressure balloon dilatation catheter for peripheral intervention by Endovastec™, Ryflumen® has performed equally well compared to other mainstream competitive products in the market in terms of various performance indicators. It ensures effective dilatation of peripheral vascular lesions, allowing for reliable vascular preparation for subsequent treatments. ”

In recent years, Endovastec™ has been actively making efforts to build a group-based operating model by establishing three subsidiaries – Bluevastec™ (Shanghai Bluevastec MedTech Co., Ltd., mainly focused on peripheral venous diseases), VasoLutions™ (mainly focused on peripheral arterial diseases), and Intervascular™ (Shanghai Intervascular MedTech Co., Ltd., mainly focused on tumor interventional medical devices). By rapidly and continuously advancing the development of diversified and full-spectrum products, Endovastec™ is committed to providing patients around the world with inclusive and total medical solutions for the field of aortic and peripheral vascular interventions.

About Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd.

Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (Endovastec™), which is a subsidiary of MicroPort Scientific Corporation, was founded in Shanghai SIMZ Century Medicine Park in 2012. Endovastec™ was granted Shanghai High-tech Enterprises, Shanghai Science and Technology Little Giant Enterprise, and the first batch of Specialized and New “Little Giant” Enterprise, AAA-level Credit Enterprise and Multinational R&D Center in China. Endovastec™ was listed on the STAR Market (Stock code: 688016.SH) of the Shanghai Stock Exchange on July 22, 2019.