Designing the release system of a biodegradable closure device for an incision in an artery, characterizing the product, including a product definition document and developing the usage scenario, visual design and detailed engineering design, manufacturing models for clinical tests, preparing a product file and accompanying the production process – examining parts from the manufacturer and updating the design accordingly.
InSeal Medical has developed a biodegradable closure device for sealing an incision in an artery following catheterization. The closure device is composed of a rigid nitinol frame with shape memory and a biodegradable sheet. The implant is folded in the release system tube, opens upon release and creates pressure against the wall of the artery with the incision. The closure device is a substitute for suturing the artery, thus shortening the duration of surgery and recovery time.