Bloomington, Ind. – Cook Incorporated’s ACHIEVE™ Drug Eluting Coronary Stent System, which uses the clinically proven benefits of paclitaxel to reduce the rate at which arteries reclog following angioplasty, has received CE Mark approval for sale in Europe. The ACHIEVE system, which features Cook’s proprietary polymer-free paclitaxel coating on stent system components provided by Guidant Corporation, is the first paclitaxel-coated coronary stent approved for sale in Europe.

“We are pleased and excited to receive the news that our ACHIEVE stent system has been approved for sale in Europe,” said Phyllis McCullough, chairman, Cook Incorporated. “This approval reinforces Cook’s leadership position in pioneering innovative medical therapies for the benefit of patients worldwide.”

CE Mark approval was granted following a comprehensive review by both the Medicines Control Agency (MCA) and British Standards Institute (BSI) of Cook’s state-of-the-art drug coating facilities and the company’s extensive animal testing and human clinical data from the ELUTES trial. The approval represents the first regulatory clearance anywhere in the world to sell the breakthrough ACHIEVE Drug Eluting Coronary Stent System.

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.