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: [[ticker: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.”
