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AUGUST 23, 2005
Cook® Receives FDA Clearance To Market Bloomington, Ind. - All of Cook Incorporated's polyurethane Turbo-Flo® Peripherally Inserted Central Venous Catheters (PICC), one of the world's most popular lines of catheters for intravenous use, have received clearance from the U.S. Food and Drug Administration to be marketed for use with power injectors for delivery of contrast media in CT studies, the company announced today. "For years, physicians and medical professionals have relied on Turbo-Flo PICC lines from Cook for venous pressure monitoring, blood sampling, and administering drugs and fluids," explained D.J. Sirota, senior product manager for Cook's global Diagnostic and Interventional Products division. "With this new indication, now the proven advantages of our catheter design can also be used to help clinicians diagnose potentially debilitating and fatal conditions." The new indication means hospitals can save money and reduce inventory by eliminating the need to stock two kinds of PICC lines, Sirota added. In addition, clinicians no longer must try to decide in advance whether a pat ent might need a power injection-rated catheter, eliminating the potential risk of replacing a previously inserted central line. The FDA notification clears Cook's Turbo-Flo, Twin Turbo-Flo and Turbo-Flo Over-The-Wire PICC lines for use with power injectors for delivery of contrast in CT studies, providing more options for optimal patient care. For more information, visit www.cookmedical.com. The world's largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., COOK® (www.cookmedical.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 drug-eluting and bare metal stents, aortic and vascular endografts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials, vena cava filters and other minimally invasive medical devices for radiology, cardiology, urology and OB/GYN, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.
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