Cook Incorporated's ACHIEVE Paclitaxel-Eluting Coronary Stent Receives First CE Mark Approval For Sale In Europe
September 3, 2002
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.
Other News Articles
- Cook Incorporated To Consolidate Its U.S. Paclitaxel-Eluting Stent Program to Support the ACHIEVE Stent
- Two Paclitaxel-Eluting Coronary Stents From Cook Incorporated Enter New Advanced Trials In Europe
- 12-Month ELUTES Data Confirm Positive Results of Higher Dosage Paclitaxel-Eluting Coronary Stents In Inhibiting Restenosis
- Cook Incorporated Receives FDA Clearance For Investigational Use Of Zilver® Vascular Stent
- Cook Wins Approval To Sell Second Paclitaxel-Eluting Stent In Europe
- Cook Incorporated To Begin First U.S. Clinical Trial Of A Drug-Eluting Non-Coronary Stent
- Cook and Angiotech Restructure License Agreement: Cook to Focus on Developing Paclitaxel-Eluting Medical Devices
for Peripheral (Non-Coronary) Market
- First U.S. Drug-Eluting Stent Trial To Treat Peripheral Arterial Disease Enrolls First Patient At Stanford University Medical Center: New treatment could benefit millions who suffer from seriously under-diagnosed disease
- Cook To Begin First International Trial of a Paclitaxel-Eluting Stent for Peripheral Artery Disease: new treatment could benefit millions who suffer from seriously under-diagnosed disease
- Two Patients Treated in First International Case Testing Drug-Eluting Stents To Treat Peripheral Arterial Disease
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