Cardiac Dimensions, Fixer of Leaky Hearts, Edges Toward European Market and Pivotal U.S. Test

Cardiac Dimensions has a dream of developing the first method for tightening up loose heart valves without requiring a surgeon to touch a scalpel. This year, the Kirkland, WA-based medical device company will get a clearer sense of whether it has successfully created such a device, and whether it will become a practical way to help as many as 3 million Americans who suffer from a common form of congestive heart failure.

The company has somehow managed to keep a low profile in the Seattle innovation community, even though it has raised more than $60 million since 2001 from a venture syndicate that includes MPM Capital, Polaris Venture Partners, Frazier Healthcare Ventures, and Johnson & Johnson Development Corporation. So I tracked down CEO Rick Stewart for an update on what the company has done, and what’s to come.

The problem his company is trying to solve, heart failure, is one of those nagging, chronic diseases that has stumped pharmaceutical and device companies for decades. It occurs when the heart is no longer able to vigorously pump enough blood to circulate through the body. The heart physically enlarges, whether because of high blood pressure, fatty buildups that clog arteries, a heart attack that damages muscle, or all of the above. It’s one of many variations of cardiovascular disease, which has long been the No. 1 cause of death in America, and, not coincidentally, the biggest market opportunity for leading medical device companies like Medtronic, Boston Scientific, and Johnson & Johnson. If things go right for Cardiac Dimensions, it believes it could open up a new market of minimally-invasive implantable devices for heart failure, with multi-billion dollar market potential, like stents that prop open clogged arteries did in the 1990s.

“There’s a lot of energy here, a lot of excited people,” Stewart says. “We’re in for a very interesting year.”

Cardiac Dimensions is specifically focused on one of the more common varieties of congestive heart failure, called mitral valve regurgitation, found in about 2.5 million to 3 million Americans, Stewart says. This is a condition in which the heart enlarges, making it so the valves that usually push blood out no longer form a proper, tight seal, which allows blood to flow back into the heart. This inefficient blood pumping makes people feel constantly out of breath, and unable to walk more than a few blocks. Eventually, the heart fails, organs fail, and people die.

Very little is done to help these patients now. Some patients simply get drugs that lower blood pressure or manage fluid balance, Stewart says. In rare cases, patients will get a surgically-implanted ring around the valve to hold it together, while others with severe disease depend on a heart transplant.

Cardiac Dimensions got its start as one of the three device companies incubated at Kirkland, WA-based Scout Medical Technologies in 2001. Ever since, it has been pursuing a simple idea for how to tighten up the mitral valve so it can open and close more normally and force blood through the body again. The technique is supposed to work by running a flexible catheter down the jugular vein into another coronary vein that has the nifty anatomical virtue of wrapping around the outside of the mitral valve. The cathether is loaded with Cardiac Dimensions’ proprietary six-centimeter nitinol alloy wire that’s super-flexible and remembers its shape. This thin device snakes around the mitral valve. It is made to prop open on both ends, creating a pressure seal against the blood vessel wall, essentially forming an anchor there. The doctor, an interventional cardiologist, then cinches up the tissue tightly to make sure the valves connect right. Everything is watched on a TV monitor, and the procedure generally takes about an hour, Stewart says. (Cardiac Dimensions has produced a video depiction of this procedure on its website.)

“There’s growing evidence if you can just make a small difference in the amount of regurgitation, or even slow down the progression of it, you can have a tremendous impact on quality of life and possibly on mortality of patients,” Stewart says.

Cardiac Dimensions isn’t going into a great amount of detail yet about the data that supports this device, … Next Page »

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