Key Clinical Data Shows That The Endeavor™
Drug-Eluting Stent Sustains Strong
Safety And
Efficacy Performance Over Time
Impressive results from ENDEAVOR I and ENDEAVOR II trials demonstrate that the stent is durable over longer follow-up periods, with no observations of late stent thrombosis
STOCKHOLM – Sept. 4, 2005 – Data from two key clinical trials presented today at the annual European Society of Cardiology (ESC) meeting shows that the Medtronic (NYSE: MDT) Endeavor™ drug-eluting stent system is sustaining its safety and efficacy benefits for patients with coronary artery disease, both in terms of freedom from potentially life threatening late stent thrombosis (clotting), and in avoiding repeat revascularization procedures to relieve recurrent symptoms.
Professor Ian Meredith, M.D., Monash Medical Centre, Melbourne, Australia, presented two-year results from the 100-patient ENDEAVOR I study conducted in Australia and New Zealand, while Dr. William Wijns, Co-Director of the Cardiovascular Center, OLV Ziekenhuis, Aalst, Belgium, presented one-year data from the 1,200-patient ENDEAVOR II Pivotal study. The presentations were made consecutively at the Clinical Update Sessions at ESC, which is one of the largest medical meetings in Europe.
The ENDEAVOR I study showed a 24-month target lesion revascularization (TLR) rate of 2.0 percent, the same percentage the trial reported a year earlier. TLR is the rate of re-treatment of the previously stented lesion, and is widely viewed by physicians as the most important measure of drug-eluting stent effectiveness. Also, there were no additional cases of stent thrombosis in the 97 study patients who received follow-up over the second 12-month period. Thrombosis is the formation of dangerous blood clots that can potentially lead to myocardial infarction or death in up to half of all cases.
“There has been no increase in TLR in the ENDEAVOR I study between 12 months and 24 months,” said Prof. Meredith, the trial’s primary investigator. “Only two patients required repeat interventions on the target lesion during the first 12 months and that number has remained constant at 24 months. These data show that the impressive early clinical results in ENDEAVOR I are sustainable to two years and the excellent safety record remains intact.”
The ENDEAVOR II study, which compared Endeavor stents to the Medtronic Driver® bare metal stent, also demonstrated no observed cases of stent thrombosis between nine and 12 months in either study arm. To date, there have been no reported late stent thromboses with the Endeavor stent in 700 patients who have 12-month or longer follow-up. The ENDEAVOR II study also demonstrated sustained efficacy, with a 12-month TLR rate of just 6.0 percent for Endeavor patients, compared to 13.2 percent in the Driver control group. This means that 94 percent of patients randomly assigned to the Endeavor stent remained free from repeat procedures of their stented vessels after one year.
“The major clinical parameters in ENDEAVOR II have remained low and stable in comparison to the Driver stent control arm, and the lack of late stent thrombosis observed in this trial with the Endeavor stent is notable,” said Dr. Wijns, a Co-Principal Investigator of the ENDEAVOR II Pivotal Trial. “We are becoming increasingly concerned about the safety of drug-eluting stents with regard to late stent thrombosis, which can be quite serious and often manifest as an acute myocardial infarction or even death.”
The Endeavor stent, which received CE Mark approval on July 29, has been evaluated in approximately 1,000 patients to date. This includes nearly 300 patients with 9-month follow-up from the ENDEAVOR II Continued Access trial, a study designed to collect additional patient data. Of these 1,000 patients, only four have experienced any stent thrombosis (0.004), but none have occurred after 30 days. The ENDEAVOR II Continued Access trial also evaluated direct stenting, which is placement of a stent without first using a balloon catheter to open the lesion. The Endeavor stent was successfully placed in 98 percent of patients undergoing direct stenting and in 99 percent of patients where vessels were pre-dilatated.
“The Endeavor stent is a very trackable and deliverable stent because it is based on the Driver bare metal stent, which is excellent,” said Jean Fajadet, Clinique Pasteur Unité de Cardiologie Interventionnelle, Toulouse, France, and a co-Principal Investigator for ENDEAVOR II. “What these longer term clinical trial results also show is that the stent’s safety and efficacy is durable as well. When you combine all these attributes, Endeavor represents a very important addition to the options we can offer our patients undergoing stent procedures.”
“Endeavor continues to perform very well in ongoing clinical trials, and these outstanding results demonstrate that the Endeavor stent offers an excellent combination of deliverability, efficacy and safety,” said Scott Ward, president of Medtronic Vascular. “We know there is growing concern among physicians about the relative safety of drug-eluting stents, and we continue to be encouraged by our strong safety profile. With more than 700 patients followed for 12 months or more, we have observed absolutely no cases of late stent thrombosis.”
Medtronic intends to present data from ENDEAVOR III in October at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, D.C. ENDEAVOR III is a 436-patient, randomized trial evaluating the safety and efficacy of Endeavor compared to the Cypher™ drug-eluting stent marketed by Cordis Corporation, a Johnson & Johnson company.
The Endeavor drug-eluting stent is based on the market leading Driver coronary stent, which is made of a cobalt alloy and has a unique modular architecture that provides enhanced deliverability over standard bare metal stents.
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 Drug Eluting Coronary Stent is an investigational device with an investigational drug (ABT-578) and is exclusively limited to 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 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
Scott Papillon, Public Relations, 707-591-7367
Yvan Deurbroeck, Public Relations, (+41 21) 802-7574
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