Cardiac Dimensions Wins EU Approval for Heart Failure Device, Aims for Market in 2012

9/29/11Follow @xconomy

Kirkland, WA-based Cardiac Dimensions, after 10 years of developing a new device to tighten up leaky heart valves in heart failure patients, is now ready to roll with its first product approved for sale in Europe.

Cardiac Dimensions said today it has been granted permission by European Union regulators to start selling its Carillon Mitral Contour System as a way of treating a common type of congestive heart failure. The company plans to start marketing the product on its own, with its own sales force, in 2012, says CEO Rick Stewart. Insurance reimbursement work is underway with payers in those countries, and Cardiac Dimensions initially has its sights on selling the product in Germany, France, the Netherlands and Belgium, he says.

The company’s device is made to treat a form 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 3.2 million people in the U.S. have loose mitral valves contributing to their heart failure, although Stewart didn’t provide numbers on the incidence in the EU.

Cardiac Dimensions won EU approval on the basis of trials that involved about 100 patients, Stewart says.

“These things [regulatory approvals] are harder and harder to get these days. The bar for [European clearance] has gone up quite a bit from the standpoint of the amount of patient experience you need to have,” Stewart says.

The EU approval offers a glimmer of hope for returns for Cardiac Dimensions’ investors, who have had to wait a long time. Stewart declined to say how much has been invested in the company, but I reported here two years ago that since 2001, Cardiac Dimensions had raised more than $60 million from a venture syndicate that includes MPM Capital, Polaris Venture Partners, Frazier Healthcare Ventures, and Johnson & Johnson Development Corporation. Cardiac Dimensions pulled in another $6.4 million last November out of a round potentially worth as much as $15 million, according to a filing with the Securities & Exchange Commission.

The company originally won EU approval for an earlier iteration of its device in 2009, but hasn’t commercialized that version because it wanted to develop an improved version to make it easier and more convenient for doctors to use, Stewart says. The company hasn’t yet set the price for its new device, but it plans to compete with a product from Abbott Laboratories, originally developed by Evalve, that now sells for 20,000 Euros, Stewart says.

Because of the large size of the market, with so many 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.

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