ShareThisLast summer, Steven Erickson was in such sad shape he could barely make it out to his vegetable garden without huffing and puffing. The retired schoolteacher from northern Minnesota would drag a chair from his kitchen out to the patch and pick his beloved heirloom tomatoes while seated among the plants.
To combat frequent chest pain, he was popping about 100 nitroglycerin pills every three days or so.
Erickson's cardiologist diagnosed him with a totally blocked left anterior descending (LAD) artery -- a main vessel to the heart that is perversely nicknamed the "Widowmaker" because of the deadly implications if it's left untreated. The sudden death of newsman Tim Russert in 2008 is an example of the devastating results of such a blockage.
The conundrum facing Erickson's doctor and many others -- finding a device that safely and effectively treats completely blocked coronary arteries -- poses a vexing challenge in cardiology. It's estimated that 1.3 million patients, roughly one-third of all those diagnosed with coronary artery disease, suffer from the condition worldwide. Treatment often involves invasive bypass surgery, or medication.
Now, a Plymouth, Minn.-based startup called BridgePoint Medical has developed a device-based technology to treat such patients. The company has initiated a 149-patient clinical trial at 18 hospitals nationwide, which includes 16 cases at Abbott Northwestern Hospital in Minneapolis so far.
Having undergone heart bypass surgery 22 years ago, Erickson, 66, was considered an unsuitable candidate for a second operation. Despite being a bit leery about being a medical subject, Erickson enrolled in the BridgePoint study at Abbott last September. The Carlos, Minn., resident is delighted with the result -- he hasn't taken a nitroglycerin pill since.
Assuming similar results in other patients, BridgePoint executives hope to submit their application to the Food and Drug Administration (FDA) for clearance by late summer, with a product launch planned for the fourth quarter of this year.
Many patients with clogged arteries are treated in a minimally invasive procedure with stents, tiny metal mesh struts that prop open the vessel, which is first widened with an angioplasty balloon. When the stent is coated with a drug, the artery is less likely to close up after the procedure.
Drug-coated stents revolutionized the way coronary artery disease is treated. Some 1.3 million angioplasty and stent procedures were performed in 2006, according to the American Heart Association, and the U.S. market for drug-coated stents is about $2 billion.
But the challenge remains for cases where the blockage is so dense and so hardened, it's impossible to insert a balloon or stent in the artery.
Over the years many device-based treatments for the condition have come and gone, according to Dr. Steven Bailey, president of the Society for Cardiovascular Angiography and Interventions, a physicians' organization.
"I've seen everything from wires to any number of mechanical solutions using lasers, ultrasound, radio frequency devices," said Bailey, who is chief of cardiology at the University of Texas Health Sciences Center at San Antonio. Boston Scientific Corporation, for example, has a device called the Rotoblader that shaves hardened plaque in the arteries, as well as an angioplasty balloon with sharp edges that can be used in such cases.
Yet no one product has been universally embraced by the clinical community, Bailey said.
Likewise, a number of startup companies that have developed devices have come and gone. BridgePoint hopes to be the exception.
BridgePoint Medical's technology actually involves two disposable devices called the CrossBoss CTO Catheter and the Stingray CRO Re-Entry System, which are snaked through the femoral artery in the groin to the blocked area of the artery, preparing it for angioplasty and a stent. Both devices were approved for use in Europe last November.
"We haven't found the Holy Grail (for treating these arteries), but this is about as close as we can come," said Dr. Nicholas Burke, an interventional cardiologist with the Minneapolis Heart Institute who treated Erickson and heads BridgePoint's study at Abbott.
BridgePoint co-founder Chad Kugler admits that marketing a new device in a space where many devices have been tried unsuccessfully might prove challenging.
"Physicians won't use things that are clinically irrelevant and that don't provide utility," he said. "But our devices have been able to bridge the gap, at least that's what the data suggest so far."
(jmmoore(at)startribune.com.)
(Distributed by Scripps Howard News Service, www.scrippsnews.com.)
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