Medtronic's Next Generation Endeavor® Resolute
Drug-Eluting Stent Shows Positive Nine-Month Results at EuroPCR Study Shows Low Adverse Cardiac Event Rate and No Stent Thrombosis
May 22, 2007, Barcelona, SPAIN --
Professor Ian Meredith, M.D., Monash Medical
Centre, Melbourne, Australia, on Tuesday presented positive nine-month results
from the Medtronic RESOLUTE clinical trial at the EuroPCR meeting in Barcelona,
Spain, with data showing a low number of adverse cardiac events and no protocol-defined
stent thrombosis. The next-generation Medtronic (NYSE:MDT - News) Endeavor® Resolute
drug-eluting stent system with new BioLinx(TM) polymer is designed to address
the special needs of patients who have complex medical conditions and is engineered
to match the duration of drug delivery with the longer healing duration often
required by these patients.
In clinical results at nine months, the Endeavor RESOLUTE trial showed no Target Lesion Revascularization (TLR), no Target Vessel Revascularization (TVR) and a Major Adverse Cardiac Event (MACE) rate of just 7.0%. Of the trial's 130 patients, 129 (99.2%) received clinical follow-up, and 95 had angiographic follow-up. In-stent late lumen loss, the study's primary endpoint, was 0.22 mm, while in-segment late loss was 0.12 mm. In-stent Angiographic Binary Restenosis (ABR) was 1.0% percent and in-segment ABR was 2.1%.
"What is most impressive about these results is that they occurred in a patient population with complex and challenging characteristics," said Dr. Meredith, the principal investigator of the trial, noting that the average lesion length in the RESOLUTE trial was 15.5 mm and nearly 82% of enrolled patients were classified as having challenging B2/C lesions. "The RESOLUTE trial enrolled a high percentage of patients with lesions that are difficult to treat, including small vessels and long lesions, and these results are extremely promising. Zotarolimus continues to be a very potent drug in preventing restenosis while the new BioLinx polymer appears to be delivering the drug as intended."
Endeavor Resolute leverages the strengths of the Endeavor stent and introduces BioLinx, a proprietary, biocompatible polymer designed by Medtronic scientists. BioLinx is different from other polymers in that its outer surface is hydrophilic (water friendly), which leads to high biocompatibility with the body. At the same time, the interior of the polymer is hydrophobic, which helps to control the drug release. Some polymers can produce an inflammatory response within the blood vessel. This can contribute to thrombosis or occlusion of the artery - outcomes that are more pronounced in patients with difficult lesions or complex medical conditions. BioLinx is a non-inflammatory polymer blend that mimics the make-up of a cell membrane to maintain biocompatibility.
"The Medtronic drug-eluting stent product pipeline is extremely strong, with clinical trial results that demonstrate an impressive combination of safety and effectiveness," said Scott Ward, president of the CardioVascular business at Medtronic. "Endeavor RESOLUTE is designed to complement Endeavor and provide physicians with a compelling choice of drug-eluting stents to match the specific needs of their patients. Medicine is very personal and these data clearly reinforce that we are achieving our mission of providing doctors with the products they need to provide the best possible care for their patients with coronary artery disease."
Two articles on the Medtronic RESOLUTE trial and the Endeavor Resolute stent will be published this week in the medical journal EuroIntervention. They are: "The next-generation Endeavor(TM) Resolute stent: 4-month clinical and angiographic results from the Resolute first-in-man trial," authored by Dr. Meredith and others; and "The Next Generation ENDEAVOR RESOLUTE Stent: Role of the BioLinx(TM) Polymer System," authored by Kishore Udipi, Medtronic Director of Polymer Research, and others.
The Endeavor Resolute stent is not yet approved in any country. Data from the Endeavor RESOLUTE clinical trial will be used to support the CE Mark application.
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: The Endeavor Drug-Eluting Coronary Stent is an investigational device with an investigational drug (Zotarolimus) and exclusively for clinical investigation in the United States.
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.
Source: Medtronic, Inc.
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