Clinical Trial Enrollment Completed for the First Endovastec™ Venous Stent
10 Oct 2021
Beijing, China—The final procedure of the pre-market multicenter clinical trial for the Vflower® Venous Stent System, a braided venous stent independently developed by Shanghai MicroPort Endovascular MedTech (Group)Co., Ltd. (“Endovastec™”), a subsidiary of MicroPort Scientific Corporation (00853.HK), was recently completed, marking the completion of enrollment in this program. The clinical trial for the Vflower® Venous Stent System is a prospective, multi-center, single-arm nationwide clinical study led by Peking Union Medical College Hospital in conjunction with The Affiliated Hospital of Qingdao University and 12 medical centers as co-participators in China. It took only 10 months from the first implantation to the enrollment completion.
The Vflower® Venous Stent System is the first venous product developed by Shanghai Bluevastec MedTech Co., Ltd. (“BluevastecTM”), a subsidiary of EndovastecTM. With regard to the design and manufacturing of this product, Bluevastec™ has leveraged the long-established technology foundation of Endovastec™ for the manufacturing of vascular stents and delivery devices, coupled with in-depth research on venous morphological characteristics and hemodynamics. Vflower® features a braided structure that provides sufficient support to iliac vein compression and meets the flexibility requirement of distal vein. In addition, the unique design of its delivery system ensures a stable and precise release.
Existing follow-up results show that the Vflower® Venous Stent System has a 100% success rate in terms of device success, technical success and procedure success which indicate that Bluevastec™'s Vflower® Venous Stent System is able to precisely locate and effectively support the lesion site during a procedure to ensure unobstructed blood flow and the stent’s conformity to the physiology of the iliac vein. The completion of the clinical implantation of the Vflower® Venous Stent System fills a gap in domestic venous stents.
Dr. Zhenyu Yuan, Vice President of Endovastec™ and General Manager of Bluevastec™, stated, “Bluevastec™ will continue to focus on developing more venous products and strengthen its venous product portfolio through in-depth basic research and rich clinical research data to offer more cost-effective solutions for more patients with venous diseases. ”