Bloomington, Ind. - Thousands of U.S. heart disease patients who might otherwise require heart bypass surgery can instead now receive a new, advanced coronary stent which for the first time allows cardiologists to nonsurgically treat blockages in many of the heart's small, severely curved blood vessels.
"Until now, cardiologists in the U.S. have been in the 'Dark Ages' of coronary stenting," said Barry George, M.D., an interventional cardiologist at Riverside Methodist Hospital in Columbus, Ohio. For more than a year, Dr. George explained, only cardiologists in Europe and other foreign markets have had commercial access to new "low profile" coronary stents which can treat blockages in many of the heart's hardest to reach blood vessels.
That changed on May 12, 1997, when the U.S. Food and Drug Administration cleared Cook Incorporated's low profile GR II® Coronary Stent for distribution in the United States, making it the first new coronary stent commercially available to U.S. cardiologists since 1994. "Our hands have been tied behind our backs with the stents we have been restricted to until now," Dr. George said, "so I have to applaud Cook and the FDA for their rapid turnaround to get this outstanding new technology into physicians' hands."
Coronary stents are stainless steel frames expanded with a balloon catheter inside an artery that has closed or appears likely to close following coronary angioplasty. By propping open the artery like a scaffold, coronary stents restore sufficient blood flow to the heart muscle so that the great majority of these patients do not need coronary artery bypass graft (CABG) surgery.
Last year, approximately 200,000 U.S. heart disease patients received coronary stents. But thousands more patients were not candidates for stent implantation because their blockages occurred in arteries so twisted and narrow, no U.S.-approved stent could be used. That left heart surgery as their only option until now.
Cook's new coronary stent moves through many of these arteries where blockages usually would have required heart bypass surgery. Because of its low profile design, the GR II stent can even pass through another stent already placed in an artery, allowing cardiologists to reach new trouble spots in the artery's narrower sections or in a smaller side branch of the blood vessel.
"There's no question this device will benefit thousands of patients. I've had cases where there was no way any of the stents previously approved by the FDA could possibly have gone in, but the GR II went in easily, and substantially altered the outcome of those patients' cases for the better," explained Dr. George. He has used the GR II as an investigational device for more than a year as part of the clinical trials FDA requires before it clears any medical device for U.S. distribution.
"FDA's clearance of Cook's GR II Coronary Stent culminates a joint effort by the medical regulatory community, working with both physicians and medical device manufacturers, to bring the best medical technology in the world to the benefit of U.S. heart patients," said Phyllis McCullough, president of Cook Incorporated. "It shows that not only doctors and medical device manufacturers see a growing need for rapid U.S. approval of safe, proven medical devices, but that the FDA has made significant advances in this area, as well."
The global use of coronary stents grew rapidly following their introduction earlier this decade. Cook's Gianturco-Roubin Flex-StentR was the first coronary stent cleared by the FDA for clinical use in the U.S. Approximately 100,000 U.S. patients have received Flex-Stent implants to date. U.S. coronary stent usage has risen tenfold in only three years, growing from an estimated 20,000 placements in 1993 to a total of 200,000 stent placements last year.
The introduction of low-profile, highly trackable coronary stent designs such as the GR II is expected to further increase the growth of stent placement worldwide as cardiologists use the devices to treat many coronary blockages which could not be treated with earlier stent designs.
Founded in 1963 with headquarters in Bloomington, Ind., Cook
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