Cook Incorporated Receives FDA Clearance For Investigational Use Of Zilver® Vascular Stent
August 15, 2002
Bloomington, Ind. – Cook Incorporated may begin investigational use of its new vascular stent in human patients under an investigational device exemption granted by the U.S. Food and Drug Administration. The company received permission to use its Zilver® Vascular Stent System to treat symptomatic vascular disease of the iliac arteries on 20 patients at four medical institutions initially, with plans to expand the study eventually to 150 patients at up to 20 investigational sites.
“Coronary stents have been among the most dramatically successful medical device innovations in the last decade, and we believe the opportunity for vascular stents is at least as exciting,” explained Kem Hawkins, president of Cook Incorporated. “Cook leadership in stents and other technologies to treat vascular disease in the peripheral arteries further enhances our position as a pioneer in innovative medical solutions for patients worldwide.”
The Zilver Stent is a self-expanding nitinol design incorporating Cook’s Z-Stent cell design for optimal strength while maintaining a strong, equally distributed radial force throughout the stented area of the artery. The Zilver design displays excellent kink resistance while conforming to tortuous anatomy. With its multiple gold radiopaque markers at each end to enhance visibility under fluoroscopy and zero percent foreshortening during deployment, the clinician can place the Zilver stent with great precision.
With international headquarters in Bloomington, Ind., privately held COOK® (www.cookgroup.com) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for stents and stent-grafts, catheters, wire guides, introducer needles and sheaths, embolization coils, tissue-engineered medical biomaterials, vena cava filters, implanted cardiac lead extraction equipment and other minimally invasive medical devices.
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