Medtronic Announces Positive Results for Endeavor RESOLUTE Drug-Eluting Coronary Stent System.
MINNEAPOLIS -- Professor Ian Meredith, M.D., Monash Medical Centre, Melbourne, Australia, today presented positive preliminary results from the Medtronic RESOLUTE clinical trial, a first-in-man study evaluating the new Endeavor RESOLUTE zotarolimus-eluting stent system. Four-month angiographic and clinical results reinforce that zotarolimus continues to be a very potent drug in preventing restenosis, even in challenging patient populations. The presentation was made Wednesday at the Cardiovascular Research Foundation's eighteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
Current drug-eluting stents (DES) do not meet all the requirements of physicians who deal with the most challenging clinical cases, such as patients with diabetes. This newest DES innovation from Medtronic (NYSE:MDT) leverages the strengths of the Endeavor stent and introduces a proprietary, new biocompatible polymer called BioLinx. This new polymer is designed to help match the duration of drug delivery with the longer healing duration often experienced by patients with complex medical conditions. BioLinx is different than other polymers in that its outer surface is hydrophilic (water friendly), which leads to high biocompatibility with the body, while the interior of the polymer is hydrophobic, which helps to precisely control the drug release.
The RESOLUTE trial enrolled 130 patients at 12 clinical centers in Australia and New Zealand, with a primary endpoint of late lumen loss (in-stent) at nine months and customary angiographic, intravascular ultrasound (IVUS) and clinical secondary endpoints. Thirty-day clinical results for 130 patients showed a Major Adverse Cardiac Event (MACE) rate of 3.8 percent, with zero Target Lesion Revascularization (TLR) and no stent thrombosis. In 30 patients with four-month angiographic follow-up, in-stent late loss was 0.12 mm and in-segment late loss was 0.05 mm. Both in-stent and in-segment binary restenosis were zero, and intravascular ultrasound (IVUS) results showed neointimal volume obstruction of 2.2 percent at four months. Stent device and lesion success was 100 percent, which means that physicians were successful in placing the assigned stents in the proper location with few complications.
"This trial enrolled patients who required smaller, longer stents and Endeavor RESOLUTE produced initial clinical and angiographic results that show great promise," said Prof. Meredith, principal investigator of the RESOLUTE trial. "By extending the drug delivery to address the delayed healing often seen in difficult patient populations, zotarolimus exhibits strong potency with low in-stent and in-segment late loss at four months. Also, acute device and procedural success was very high, particularly when the long lesion lengths were considered."
The polymers on some drug-eluting stents can produce an inflammatory response within the blood vessel, which can lead to thrombosis and occlusion of the artery. This is more pronounced in patients with complex medical conditions. BioLinx is a non-inflammatory polymer blend that mimics the make-up of a cell membrane to maintain biocompatibility. As a result, it offers uniform drug dispersion, sustained and controlled elution, and the opportunity for multiple drug platforms.
"Current drug-eluting stents have significantly reduced restenosis rates for most patients, but there are still many unmet clinical needs," said Scott Ward, president of Medtronic's vascular business. "Patients with diabetes, diffuse and multi-vessel disease, chronic total occlusions and other challenging medical conditions still have lower than desired clinical outcomes and require better treatment options. We've combined our proprietary new BioLinx polymer with zotarolimus to address the specific healing needs of these patients. Endeavor RESOLUTE may provide physicians with a new clinical option for the treatment of their most challenging patients with coronary artery disease."
Medtronic will present the full nine-month clinical and angiographic results from the RESOLUTE trial at a future medical meeting.
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 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 28, 2006. Actual results may differ materially from anticipated results.
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|Date:||Oct 25, 2006|
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