Cardiac Dimensions did what it said it was going to do. The Kirkland, WA-based medical device company, which we profiled earlier this week, has won permission from European regulators to start selling its first product, a minimally-invasive implanted device to tighten up leaky heart valves.
The company has gotten its clearance in Europe through what is known as a CE Mark approval process, said CEO Rick Stewart in an e-mail. Cardiac Dimensions will now be in position to have talks with larger medical device companies that can help it distribute and market the device, called Carillon Mitral Contour System. The product still has a long way to go before getting approval in the U.S. Cardiac needs to run a 300-patient clinical trial starting this year, and if results are positive, it could be on the market by the end of 2011 or early 2012, Stewart says.
The device is made to treat a type of congestive heart failure, known as mitral valve regurgitation, in which the heart is no longer able to vigorously pump blood throughout the body. The reason is that the mitral valve loosens up, meaning that when the heart pumps blood out, some of the blood backflows into the heart. Cardiac Dimensions aims to tighten up the valve, and prevent the backflow, by using a catheter to insert a super-flexible alloy wire around the valve to cinch it up tight again. An estimated 3 million people in the U.S. have the illness, the company says.
Cardiac Dimensions hasn’t published the data that supported its European filing, but Stewart told me it has been tested in 72 patients around the world, and it has reached all of the goals researchers set in studies. Whether the data is actually good enough to convince governments, or insurers, to pay for it will be one of the next big steps the company will have to take.
