Bloomington, Ind. - Cook Incorporated, manufacturer of the first coronary stent cleared for clinical use in the United States, has received U.S. Food and Drug Administration clearance to market its new low-profile, highly trackable GR II® Coronary Stent in the U.S.
FDA's clearance notification on May 12, 1997 makes the Cook GR II® the first new coronary stent cleared for clinical use in the United States since 1994. Cook's earlier coronary stent, the Gianturco-Roubin Flex StentR, has been commercially available in the U.S. since June 1993, with more than 100,000 U.S. implants.
Cook's GR II® Coronary Stent, available in 20 mm and 40 mm lengths, is indicated for treatment of acute or threatened vessel closure in patients with failed interventional therapy in vessels with reference diameters in the range of 2.1 mm to 4.0 mm.
The GR II® Coronary Stent allows placement in a wide variety of lesions. Its clinically significant design features include:
- Flat metal design to maximize vessel wall support (15-20%
surface area contact) and provide improved
radial strength over other stent designs;
- Longitudinal spine to maintain constant stent length during
placement;
- Low profile design for compatibility with 6.0 or 7.0 Fr
guiding catheters and 0.014" wires with increased trackability in
tortuous and distal vessels;
- Gold radiopaque markers at both ends of the stent to improve
visualization and allow precise placement;
- Access to vessel side branches after deployment;
- "State-of-the-art" stent delivery balloon catheter that
accepts higher inflation pressures to optimize stent
deployment in complex lesions;
- Available in the world's only 40 mm length coronary stent
(for long lesion stenting), as well as 20 mm;
- Manufactured in diameters from 2.5 mm to 4.0 mm for reference vessel diameters ranging from 2.1 mm to 4.0 mm
"Even before bringing the first coronary stent to the U.S. marketplace, Cook, through its cardiology division, was already working with cardiologists to create an improved stent design that recognized the coronary anatomy's unique requirements," explained Phyllis McCullough, president of Cook Incorporated. "The success of our new GR II® coronary stent, which is now available around the world, demonstrates Cook's unique ability to respond quickly to rapid changes in the medical industry with products developed in conjunction with physicians to enhance patient outcomes."
Founded in 1963 with headquarters in Bloomington, Ind., Cook Incorporated (http://www.cookgroup.com/) has become a leading global manufacturer and distributor of medical products and interventional devices for radiology, cardiology, oncology, neurology, general surgery, critical care and other medical disciplines.
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