Medtronic Receives CE Mark Approval For Endeavor™
Drug-Eluting Coronary Stent
System
First cobalt alloy DES to be launched in 40 countries outside the U.S.
SANTA ROSA, CA, April 12, 2005 – Medtronic, Inc. (NYSE:MDT) today announced that it has received CE Mark (Conformité Européenne) approval for the commercial sale of the Endeavor™ Drug-Eluting Coronary Stent with the Rapid Exchange Delivery System in European Union member countries. The Endeavor system – the first cobalt alloy platform on the drug-eluting stent (DES) market – offers best-in-class deliverability, excellent clinical results and a strong patient safety profile.
“We are very pleased to provide physicians and patients with Medtronic’s high performance Endeavor drug-eluting stent system,” said Scott Ward, president of Medtronic Vascular. “Physicians will now have a broader choice among the drug-eluting stents that are available to treat their patients. We believe the Endeavor system offers a powerful combination of deliverability, efficacy and safety that is unmatched by any other commercially available stent.”
Drug-eluting stents are tiny mesh tubes coated with medicine and used to prop open arteries during angioplasty procedures. They have been proven to be superior to traditional bare-metal stents at reducing the rate of repeat procedures due to re-clogging of arteries (restenosis) in patients with coronary artery disease.
Ward noted that Medtronic sales representatives and customer support staffs are fully trained, and the company has an ample supply of Endeavor systems to support an aggressive global rollout. In fact, the company plans to conduct a simultaneous worldwide launch in approximately 40 countries outside the United States.
“Our people and our facilities are well-prepared to deliver Endeavor to physicians and patients with no delays,” Ward said.
Dr. Jean Fajadet, M.D., Clinique Pasteur Unité de Cardiologie Interventionnelle, Toulouse, France, and one of the co-principal investigators of the ENDEAVOR II pivotal trial, commented: “The results from the ENDEAVOR trials to date have been both comprehensive and positive,” said Dr. Fajadet. “I have had experience with each of the drug-coated stents on the market, and I believe that physicians in the European Union and elsewhere around the world will find that Endeavor represents an excellent course of treatment for their patients.”
Endeavor Clinical Results Strong
Medtronic reported strong clinical results in the ENDEAVOR II clinical trial, including a 47 percent reduction in Target Vessel Failure (TVF), the study’s primary endpoint, between the Endeavor arm and the control group. It also demonstrated a 62 percent reduction in Target Lesion Revascularization (TLR). Safety data from the ENDEAVOR II study indicated a 50 percent reduction in the Major Adverse Cardiac Event (MACE) rate compared to a conventional bare-metal stent, and just a 0.5 percent rate of stent thrombosis at 30 days – with no late thrombosis beyond 30 days and no late stent malapposition. Thrombosis is the formation of dangerous blood clots that can lead to myocardial infarction or death.
“The overall clinical results of the Endeavor stent are impressive, and I think Endeavor will be a valuable addition to the drug-eluting stent marketplace,” said William Wijns, M.D., Co-Director of the Cardiovascular Center, OLV Ziekenhuis, Aalst, Belgium, and a Co-Principal Investigator of the ENDEAVOR II trial. “Endeavor has proven to be highly deliverable and is effective in reducing clinical restenosis. It also offers an excellent safety profile, which is important to both physicians and patients.”
Medtronic will report results of the ENDEAVOR III trial at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in October, and a key fourth trial, ENDEAVOR IV, also is underway. The four trials will provide data on more than 2,000 Endeavor patients and will complete the package of information needed for submission to the FDA for approval in the United States.
The Endeavor Drug Eluting Coronary Stent System combines the world-renowned Driver bare-metal stent with a Sirolimus-analogue drug, known as ABT-578, and a biocompatible polymer, called PC Technology, to treat coronary artery disease. ABT-578 is a unique, patented compound licensed to Medtronic by Abbott Laboratories and is designed to inhibit the cellular process that leads to restenosis. Medtronic also licenses Abbott’s proprietary phosphorylcholine polymer coating technology (PC Technology?), which is licensed under patents owned by Biocompatibles, Ltd. PC Technology is designed to serve as the “delivery matrix,” which controls the elution, or release, of ABT-578 directly into the arterial wall.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, U.S.A., is the global leader in medical technology, alleviating pain, restoring health, and extending life for millions of people around the world. European headquarters are in Tolochenaz, Switzerland.
Caution: The Endeavor™ Drug Eluting Coronary Stent is an investigational device in the United States. The device is limited by federal (or United States) law to investigational use only.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 29, 2005. Actual results may differ materially from anticipated results.
Contacts:
Rachael Scherer, Investor Relations, 763-505-2694
Jeff Warren, Investor Relations, 763-505-2696
Rob Clark, Public Relations, 763-505-2635
Scott Papillon, Public Relations, 707-591-7367
Medtronic, Inc. |
