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. ”