Healthcare Industry News:  stent thrombosis 

Devices Interventional Cardiology Regulatory

 News Release - October 22, 2007

Medtronic Receives CE Mark for Endeavor(R) Resolute Drug-Eluting Stent

New Addition to Company's International Stent Portfolio Expands Treatment Options for Patients with Coronary Artery Disease; First Commercial Implant Performed in Europe by Prof. Serruys at Heartcenter Rotterdam

MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ), announced today that it has received CE (Conformité Européene) Mark approval for the commercial sale of the Endeavor® Resolute Drug-Eluting Coronary Stent and plans to launch the product outside the United States earlier than originally projected.

The Endeavor Resolute stent will be launched in more than 50 countries in Europe, Asia, the Middle East and Africa by the end of 2007 – making Medtronic the first company to offer two internally developed drug-eluting stent options for the treatment of coronary artery disease, a condition affecting millions of people worldwide. The new stent is not approved in the United States.

Endeavor Resolute adds an innovative new drug-eluting stent to Medtronic’s international stent portfolio, which also includes the Endeavor drug-eluting stent and the Driver® bare-metal stent. The expanded portfolio provides physicians with a greater variety of stent choices to cover a wide range of patient needs.

Endeavor Resolute uses a proprietary new biocompatible polymer called BioLinx™. The BioLinx polymer is designed to confer the same biocompatibility as the Endeavor stent’s phosphorylcholine (PC) polymer while extending the duration of drug exposure in the vessel. Developed by Medtronic scientists, BioLinx is the first polymer created specifically for use on a drug-eluting stent. The BioLinx polymer features a unique blend of hydrophilic and hydrophobic elements for optimal performance. Extensive preclinical studies have established the biocompatibility and drug delivery capabilities of the BioLinx polymer.

Prof. Patrick W.J.C. Serruys of the Heartcenter Rotterdam in The Netherlands performed the first commercial implant of the Endeavor Resolute stent on October 10. “We now have a new drug-eluting stent for our patients with a breakthrough in coating technology,” said Prof. Serruys. “This new BioLinx polymer has been fully assessed, both on biological and pharmacological parameters, and found to be compatible with blood, endothelial and smooth muscle cells.”

Prof. Serruys added: “Endeavor Resolute provides the excellent safety profile of the Endeavor stent with extended delivery of the drug zotarolimus. To further evaluate the safety and efficacy of the new stent in real-world clinical practice, we have designed a post-market European study involving more than 2,300 patients.”

Patients treated with the Endeavor Resolute stent in the initial RESOLUTE clinical trial required no repeat procedures through nine months and had experienced no protocol-defined stent thrombosis through 12 months of follow-up. In-stent late lumen loss at nine months, the study’s primary endpoint, was met at 0.22 mm ± 0.27 mm, providing assurance of vessel healing in the targeted range while preventing repeat procedures. Among the trial’s 130 patients, only one required clinically-driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR) through 12 months. The incidence of major adverse cardiac events was 8.5 percent through 12 months.

The 12-month results from the RESOLUTE trial are available at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, DC, in abstract TCT-397. “The RESOLUTE clinical results are impressive considering the enrolled patients presented with especially complex and challenging characteristics,” explained the trial’s principal investigator, Prof. Ian Meredith of Monash Medical Centre in Melbourne, Australia. These patients on average had longer lesions at 15.5 mm, and 82 percent of the patients were classified as having very complex lesions.

“Endeavor Resolute continues to deliver impressive clinical outcomes,” said Prof. Meredith. “The stent’s drug-and-polymer combination has successfully reduced restenosis in a particularly challenging patient group while maintaining an excellent safety profile.”

Medtronic plans additional clinical trials of the Endeavor Resolute stent as part of a comprehensive program to characterize the stent’s long-term safety and efficacy in a variety of patient populations. The program will enroll approximately 13,000 patients in a series of randomized controlled trials and registries in the United States and internationally.

Endeavor Resolute leverages the strengths of the Endeavor drug-eluting stent, which was launched in Europe in July 2005 and is now available in more than 100 countries outside the United States. They share the same cobalt alloy stent platform, which provides excellent radial strength and conformability to the vessel wall, and both use the non-cytotoxic drug zotarolimus. Both of Medtronic’s drug-eluting stents also use highly biocompatible polymers.

“The Endeavor Resolute drug-eluting stent and the novel BioLinx polymer represent two important achievements of our robust product pipeline and demonstrate our commitment to innovation in interventional cardiology,” said Scott Ward, president of the CardioVascular business at Medtronic. “With the combination of Driver, Endeavor and Endeavor Resolute, Medtronic is delivering safe and effective options for physicians to treat a broad range of patients with coronary artery disease.”

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Caution: In the United States, the Endeavor and Endeavor Resolute drug-eluting coronary stents are investigational devices with an investigational drug (zotarolimus) and are exclusively used for clinical investigation.

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 27, 2007. Actual results may differ materially from anticipated results.


Source: Medtronic

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