New England Patriots linebacker Tedy Bruschi suffered a stroke back in 2005, because he had a hole in his heart that allowed a blood clot to pass to his brain. State-of-the-art treatment at the time was for doctors to do surgery, patching it up with an implantable metal-and-fabric device.
If Redmond, WA-based CoAptus Medical is successful, then a few years from now people like Bruschi will have a new option: a non-invasive way to seal up these heart defects without any implant. This week, the Redmond, WA-based company raised $3 million to pursue tests to see if it can make this idea work. CoAptus is led by president Joe Eichinger, and is backed by David Auth, the founder and former CEO of Heart Technology, who sold that company to Boston Scientific for more than $500 million in 1995.
CoAptus is seeking to solve a fairly common defect called a patent foramen ovale, which is a flap-like opening between upper chambers of the heart, Eichinger says. It usually closes up naturally after a baby is born, but doesn’t for many people. The defect, found in 20 to 25 percent of the U.S. population, is normally not a big problem, but it has been linked to higher risk of severe migraine headaches and stroke, he says. If this passageway remains open, even a relatively healthy person like an NFL linebacker can form blood clots while sedentary on a long flight, leading clots to travel to the brain and cause trouble. Something like 40 percent of the 750,000 strokes suffered in the U.S. each year are from unknown causes, and heart defects are one possible culprit, Eichinger says.
Of course, not everyone with the defect will seek out a procedure to prevent a stroke. But CoAptus hopes patients might be more inclined to get the procedure if it can seal up the defect without leaving behind an implant that might someday cause complications, like heart perforations, blood clot formation, or make it more difficult to have open-heart surgery if needed.
“Our whole claim is that we don’t leave anything behind in your heart,” Eichinger says.
Here’s how it’s supposed to work: CoAptus is using radio-frequency (RF) waves to heat up the tissue near the flap in the heart, which he described as being like a shirt pocket. The company’s device is mounted on the tip of a catheter that is threaded up from the femoral vein in the leg, into the heart, where it grasps the two sides of tissue, and essentially welds them together, Eichinger says.
CoAptus was founded in 2003, and had raised about $10 million prior to the latest financing, Eichinger says. It recently went through a reorganization, in which it briefly laid off its seven employees, while it converted some debt from Boston Scientific into an equity stake, he says. The company plans to use the new money for some more animal testing before it hopes to start a feasibility study in humans in late 2009. The first study should be in five to seven patients in Germany, he says.
“We have been attacking this problem vigorously under the Coaptus banner since 2003 and now feel optimistic that our RF tissue welding approach is the answer,” Auth says. “The recent funding is intended to show early success in humans now that we have had excellent results in animals.”
The competition for CoAptus in this space comes mainly from three companies—Boston-based NMT Medical; Plymouth, MN-based AGA Medical; and W.L. Gore Associates, which has a medical products division in Flagstaff, AZ. They all require an implant to be left behind, so CoAptus hopes to differentiate itself by sealing the wound without any implants, Eichinger says. Leaving the heart without any implants could be important for many patients, because the implants might prevent patients from being eligible for other procedures in the future.
“You don’t know 20 years from now what kind of medical valve procedures they might be doing,” Eichinger says.
Further in the future, CoAptus hopes to show that closing up these heart defects can have a benefits for migraine sufferers, Auth says. A prominent interventional cardiologist at Swedish Medical Center in Seattle, Mark Reisman, has told the company that patients who have had this procedure done have mentioned that they are greatly relieved to see their migraines go away.
Reisman has advised the company that it’s unlikely that physicians and the FDA would consider the risks of the procedure to be worth the benefit of reducing migraines. Yet this kind of potential side-benefit sounds to me like the sort of thing that might catch on via social networking websites as patients talk about the pros and cons of the procedure.
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