Cardiac Dimensions Wins EU Approval for Heart Failure Device, Aims for Market in 2012
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potential patients eligible for a high-priced device, Stewart says the opportunity here is much bigger than it is with one of the other hot areas of medical devices for the heart—known as percutaneous aortic valve repair. That’s a technique in interventional cardiologists seek to thread a catheter through the femoral artery of the leg, and up into the chest to repair the heart’s aortic valve without cracking open the chest and doing surgery.
One of the leaders in the percutaneous valve space was CoreValve, which was acquired for $700 million upfront by Medtronic in 2009. Last year, Boston Scientific acquired another player in that field, Los Gatos, CA-based Sadra Medical, for $193 million upfront.
“There is no doubt it can be bigger than the CoreValve market,” Stewart says, adding, “this will be a high Average Selling Price product. Gross margins will be very attractive.” He adds that Cardiac Dimensions could become profitable on the basis of the first four European countries alone, and that it has an active application on file with the FDA for permission to start selling the product in the much-bigger U.S. market. He didn’t offer any timeline on when Cardiac Dimensions might be able to secure FDA approval.
While Stewart didn’t want to go into specifics of the engineering improvements of the new device, he said Cardiac Dimensions will position its product as one that’s simpler to use than the competing Abbott product and as the one that can be implanted faster. Plus, the Cardiac Dimensions device is made so that if it doesn’t work and the doctor wants to remove it for some reason, he or she can do that through a minimally invasive procedure, Stewart says.
Cardiac Dimensions currently has about 35 employees, Stewart says. The company plans to raise more money to help drive its early sales in Europe, and it will consider whether to work with a partner, he says.