Medtronic Provides Update on Endeavor™
Drug Eluting Coronary Stent Program
CE Mark Approval On Track for Early 2005
SANTA ROSA, Calif. – Nov. 17, 2004 – Medtronic, Inc. (NYSE:MDT) today announced the completion of additional milestones in its effort to achieve Conformité Européenne (CE) Mark approval of the Endeavor™ Drug Eluting Coronary Stent for commercial use outside of the United States.
Medtronic announced that it has provided all of the required submissions for regulatory review of the Endeavor stent for CE Mark approval to the designated European regulatory authority. In addition, the European regulatory authority has completed site quality inspections of Medtronic’s drug eluting stent manufacturing operations in Santa Rosa, Calif., and Galway, Ireland, and reported no non-conformances. At completion of the audit, the regulatory authority communicated that Medtronic had met all of the necessary European quality system requirements for a drug-device combination product and would recommend full certification of both facilities.
“These substantial achievements in our Endeavor program highlight an extensive amount of work and investment by our people over the past several months,” said Scott Ward, president of Medtronic Vascular. “We have invested more than $50 million in capital improvements at these facilities and have brought on more than 1,000 people to ensure that we deliver a high-quality product that is readily available for physicians around the world. Our people and our facilities are well-prepared to bring this product to physicians and patients when we receive the CE Mark, which we anticipate will be in early 2005.”
Medtronic also announced that it has filed its Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration to begin its ENDEAVOR IV Clinical Trial in the United States and Canada. Medtronic intends to begin patient enrollment in ENDEAVOR IV in December. As previously announced, Medtronic will present eight and nine-month clinical results from its ENDEAVOR II Clinical Trial at the American College of Cardiology (ACC) annual conference in March 2005.
The Medtronic Endeavor Drug Eluting Coronary Stent system combines Medtronic’s Driver™ Coronary Stent, the drug ABT-578 and a PC polymer into a drug eluting stent system designed to reduce restenosis.
Medtronic’s Endeavor stent system utilizes the original Driver Coronary Stent, which is approved in both the United States and Europe for treating large and small vessels (small vessels outside the United States only). The Driver Coronary Stent leverages Medtronic’s long expertise in utilizing implantable metal alloys, such as cobalt chromium alloys. Medtronic’s Driver cobalt alloy stent is designed to allow for thinner struts, a lower profile and better deliverability in the vessel without compromising radial strength and visibility.
ABT-578 is a unique, patent-protected compound licensed to Medtronic by Abbott Laboratories. ABT-578 is designed to inhibit the cellular process that leads to restenosis. Medtronic also licenses Abbott’s proprietary phosphorylcholine polymer coating technology (PC Technologyä 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.
About Medtronic
Medtronic, Inc., headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.
Caution: The Endeavor™ Drug Eluting Coronary Stent is an investigational device. The device is limited by federal (or United States) law to investigational use only.
Any statements made about the company’s anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 30, 2004. Actual results may differ materially from anticipated results.
Medtronic Media Contacts:
Rachael Scherer, Investor Relations, 763-505-2694
Rob Clark, Public Relations, 763-505-2635
Source: Medtronic, Inc.
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