TEL AVIV, Israel, Oct. 1, 2020 /PRNewswire/ -- Vascular Graft Solutions Ltd. (VGS), an Israel-based innovative commercial-stage medical device company, announced today that the China National Medical Products Administration (NMPA) granted Innovative Medical Device Designation for VEST™, an external stent for vein grafts in coronary artery bypass surgery. VEST™ was proven to mitigate the underlying factors leading to vein grafts disease; disturbed flow pattern, high wall tension, and progression of intimal hyperplasia.
NMPA provides a fast-track approval pathway for breakthrough medical devices. The granted priority manifests in the classification determination, pre-clinical testing, QMS auditing, and NMPA review and approval processes.
"We are excited that VEST™ has been granted the Innovative Device Designation," said Eyal Orion, M.D., founder, and CEO of VGS. "Only one out of five medical devices granted innovative device status by NMPA in 2019, of which only 20% were of overseas companies. This recognition will accelerate our communications with the NMPA as well as shorten the time-to-market of VEST™ in China. This is an important milestone in our journey to improve the clinical outcome of coronary bypass surgery."
The innovative medical device designation provides a support platform for the assigned technologies to enter the Chinese market. VEST is now officially listed on the NMPA website and VGS was assigned a designated NMPA reviewer which will consult the company on the clinical plan and guide the company through the registration process. In addition, this recognition will prioritize the technical review and QA inspection. This translates to an expedited and qualitative process and ultimately final approval by NMPA.
About VGS and VEST
VGS is a privately held company located in Tel Aviv, Israel. The company develops novel solutions in the field of cardiovascular surgery. VEST is a CE marked external support device for treatment of saphenous vein grafts in coronary bypass procedures. VEST targets the root causes of vein graft failure. The device underwent several randomized trials in leading heart centers in Europe, was implanted successfully in approximately 5,000 patients and is commercialized in the EU, Australia, Mexico and South Africa.
VP Business Development VGS
SOURCE Vascular Grafts Solutions