CoreValve received CE Mark approval yesterday for its non-invasive heart valve, putting the Irvine, CA, company out in 
front of other startups working on similar technologies. The company’s ReValving System inserts the artificial valve through a catheter and permanently implants it over the diseased valve (opposed to replacing it). The small size of the delivery catheter is a key element of the system because it improves overall maneuverability and valve placement while eliminating the need for surgical cut-down of the femoral artery.
Red Herring reports that three other small companies have similar products in the works: “Sadra Medical, a start-up based in Campbell, California, and EndoVale of Princeton, New Jersey, both have competing projects in early development. Edwards Lifescience, an international company specializing in devices for cardiovascular disease, is the only competitor with a late stage product.”
Although the frontrunner, CoreValve is not rushing to bring its product to the European market. The company said in a press release that it will not not immediately market the ReValving System. Instead, it plans to continue evaluating the system to make sure cardiologists are fully trained; it did not specify how long the expanded evaluation would go on. In the U.S., according to Red Herring, CoreValve has begun discussions with FDA and plans to start trials before the end of this year.