Last September, cardiac medical device company, Kips Bay Medical announced that the Food and Drug Administration had essentially rejected its investigational device exemption application for a pivotal study because it needed additional information.
On Wednesday, Kips Bay Medical, based in Minnesota, announced that FDA had responded positively to the additional information it provided paving the way for a formal IDE application. The FDA has 30 days to respond to this second IDE submission.
Kips Bay Medical makes the eSVS Mesh device that supports leg veins grafted to the heart during coronary artery bypass surgery.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
If the FDA approves the IDE application, then the publicly-held company can include four U.S. sites in its ‘eMESH I’ clinical feasibility study of its eSVS Mesh device currently being conducted in Europe.
“We are very excited that U.S. cardiac surgeons will also have the opportunity to work with our eSVS Mesh. Following an estimated 350+ implants we have achieved overseas, this represents a significant milestone in our ability to demonstrate the performance of our eSVS Mesh technology.” said founder Manny Villafaña, in a newsrelease. “Having previously navigated this process with other companies that I founded, this is a significant step for Kips Bay Medical.”
