clinical trial enrollment completed for the first endovastec™ venous stent2021-云顶国际

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. ”