Vascular Graft Solutions recently announced that its Vest external stent received innovative medical device designation from the China National Medical Products Administration.
The Vest external stent is designed for vein grafts in coronary artery bypass surgery. It has been proven to mitigate the underlying factors leading to vein grafts disease, disturbed flow pattern, high wall tension and progression of intimal hyperplasia.
“We are excited that Vest has been granted the innovative device designation,” CEO and founder Eyal Orion said in a news release. 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.”
China’s innovative medical device designation gives companies a support platform for the assigned technologies to enter the market in China.
The Vest device is now listed on the NMPA website and Vascular Graft Solutions was assigned a designated NMPA reviewer.