Cook Wins Approval To Sell Second Paclitaxel-Eluting Stent In Europe
September 5, 2002
Bloomington, Ind. – Just days after receiving clearance to sell its ACHIEVE Drug Eluting Stent System in Europe, Cook® now has received CE Mark approval to market its paclitaxel-coated V-Flex Plus PTX Coronary Stent System in the European Union. Cook will begin selling the V-Flex Plus PTX stent to European medical institutions immediately.
The V-Flex Plus PTX, manufactured using Cook stent components with the company’s proprietary polymer-free paclitaxel coating, received CE Mark approval following a comprehensive review by both the Medicines Control Agency (MCA) and Lloyd’s Register Quality Assurance (LRQA). Animal testing and human clinical data from the ELUTES trial supported the regulatory submission, Cook officials added.
“This is a landmark achievement for our organization. Having the first two paclitaxel-eluting coronary stents approved for sale in the European Union confirms Cook’s unwavering commitment to developing and introducing state-of-the-art medical devices worldwide,” said Phyllis McCullough, executive vice president of operations, Cook Group Incorporated. McCullough said the company has no plans at this time to introduce the V-Flex Plus PTX stent to the U.S. market.
“We congratulate Cook on this impressive achievement. It is incredibly rewarding to see years of restenosis research culminate in the commercialization of a revolutionary drug-coated coronary stent,” said William L. Hunter, M.D., chairman and CEO of Angiotech. “Safety and efficacy are our top priority, and patients who suffer from coronary heart disease will benefit from Cook’s prudent approach to build a safe and effective paclitaxel-coated stent that dramatically reduces stent failure.”
In 1993, Cook, a world leader in the development of drug-eluting coronary stent technology to combat restenosis, introduced the first commercially available coronary stents to the United States. These tiny wire scaffold-like devices, which became the most successful innovation in interventional cardiology of the 1990s, are inserted inside blocked sections of coronary arteries and expanded into place using a balloon catheter in a procedure called angioplasty. One drawback to their success in maintaining blood flow through the affected artery, however, is that in approximately 25 percent of cases, according to medical studies, a new blockage develops at the site of the angioplasty due to scar tissue growth and inflammation, a condition referred to as restenosis.
Paclitaxel acts to prevent excessive cell regrowth at the site of the angioplasty, which human clinical research has shown produces a clinically significant reduction in restenosis. In Cook’s highly successful ELUTES clinical trial, the V-Flex Plus PTX demonstrated a restenosis rate of just 3.1 percent due to its paclitaxel coating, which acts to prevent excessive cell regrowth at the site of the stent placement. Cook’s polymer-free, paclitaxel-eluting V-Flex Plus PTX stents are not approved for sale in the U.S. at this time.
Cook Group Incorporated and Guidant Corporation jointly announced on July 30, 2002 that Guidant has agreed to acquire Cook Group Incorporated in a stock-for-stock transaction. The parties anticipate closing in early 2003, subject to the satisfaction or waiver of conditions.
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 Incorporated's ACHIEVE Paclitaxel-Eluting Coronary Stent Receives First CE Mark Approval For Sale 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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