Cook Incorporated To Consolidate Its U.S. Paclitaxel-Eluting Stent Program to Support the ACHIEVE Stent
March 12, 2002
Bloomington, Ind. – Buoyed by the rapid completion of enrollment in the U.S. clinical trial of its ACHIEVE drug-eluting coronary stent to be sold to and distributed worldwide by Guidant, Cook Incorporated announced today it will consolidate its U.S. paclitaxel-eluting coronary stent program to support that device exclusively.
Cook Incorporated’s PATENCY trial of the Cook Logic PTX Drug-Eluting Coronary Stent will not be completed, company officials confirmed. The company will focus its domestic efforts in drug-eluting coronary stents on ensuring the success of the ACHIEVE device after its anticipated U.S. introduction in 2003. Cook Incorporated will, however, introduce its V Flex Plus PTX drug-eluting coronary stent in Europe using newly developed balloon catheter technology upon approval of its CE Mark submission, which is expected in the second quarter of 2002.
“Given the unusually rapid enrollment of more than 1,000 patients in the clinical trial of our ACHIEVE stent and our strong expectations for the widespread acceptance of both the ACHIEVE and V Flex Plus PTX stents once they receive regulatory approval, we made a business decision to dedicate our resources and manufacturing capacity to ensure the successful launch of these two new drug-eluting coronary stents,” explained Phyllis McCullough, chairwoman of Cook Incorporated.
Cook will complete its ongoing U.S. clinical trial of the uncoated Logic Coronary Stent, the company confirmed. It also will continue its expedited research and development efforts for future paclitaxel-eluting coronary and peripheral stents for the U.S. and overseas markets.
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
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- 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 Incorporated's ACHIEVE Paclitaxel-Eluting Coronary Stent Receives First CE Mark Approval For Sale In Europe
- 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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