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

1/26/09Follow @xconomy

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, which it calls the Carillon Mitral Contour System. The company is holding back most of its results until it can get them published in a peer-reviewed journal, or presented at a medical meeting, which it expects to do this year, Stewart says.

Still, he did give some guidance. So far, the company has done two clinical studies in Europe and two more in other parts of the world, Stewart says. A total of 72 patients have been treated. The trials looked at visual images, via echocardiogram, before and after the procedure to show how much it reduced the amount of backflow of blood into the heart. Doctors also tested patients on how far they could walk in a standard six-minute walking test before and after the procedure. Then the patients got follow-up exams for as long as six months. The company has met all of its clinical trial goals, Stewart says.

He wouldn’t get into details about the safety profile of the procedure, other than to say the company is satisfied and encouraged with the adverse event rate. Still, there are side effects to watch out for. Since these patients are frail, they need to be screened to be in good enough shape to undergo anesthesia and subjected to chemicals that help doctors with internal organ imaging, Stewart says. Then doctors need to be careful not to puncture the veins surrounding the heart with the catheter, which is known to happen with other heart procedures, he says.

Based on results so far, the company is “very close” to getting approval to market the device in Europe, which could pave the way for Cardiac Dimensions to find a marketing partner in those territories, Stewart says. It will take longer in the U.S. By the end of June, Cardiac Dimensions should have enough follow-up data from Europe to go ahead and start a larger, pivotal clinical trial in the U.S. That trial, of an estimated 300 patients, will require longer term follow-up of probably a year to pass muster with the FDA, Stewart says. If the company can get the green light for that study on schedule, it could get FDA clearance to sell the device in the U.S. by the end of 2011 or early 2012, Stewart says.

Cardiac Dimensions believes it is “clearly in the lead” over competitors working on minimally invasive mitral valve repair, Stewart says. Irvine, CA-based Edwards Lifesciences (NYSE: EW) is closest behind, but has recently redesigned its device and is restarting clinical trials in Europe, Stewart says. Wilmington, MA-based Viacor is another small private company that has done some human testing, he says.

No price has been set for the Carillon device yet, but “it will be much more expensive than a stent,” Stewart says. The company has modeled a variety of prices, from $12,000 to $25,000, but hasn’t settled on a figure, Stewart says. The company has been watching Edwards and Irvine, CA-based CoreValve, which has introduced aortic valve replacement devicesrumored to fetch prices of more than $22,000 since they were introduced in Europe last year, Stewart says.

As long as the clinical trial data can support such a price, then all of the big medical device companies will surely see this as a market with enough potential to make up for the stagnating market with stents, Stewart says.

“The big device companies need a new product category,” he says. “This is perfect for them.”

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