Navigation Links
Medtronic Updates Long-Term ENDEAVOR I-II Clinical Data Showing,Sustained Safety and Significant Reductions in Repeat Procedures

BARCELONA, Spain--(BUSINESS WIRE)--May 22, 2007 - Medtronic (NYSE:MDT) today presented new long-term data from the ENDEAVOR clinical trial program reinforcing the existing safety and efficacy profile of the Endeavor(R) drug-eluting coronary stent system. Four-year results from the 100-patient first-in-man ENDEAVOR I trial and three-year results from the nearly 1,200 patient ENDEAVOR II trial demonstrate that Endeavor is associated with sustained safety, significant reductions in repeat procedures and no late stent thrombosis in either trial using the pre-specified trial protocol definitions. The ENDEAVOR II study also showed that the Medtronic Driver(R) bare metal stent offers consistent and durable long-term clinical results.

The data was presented by Andreas Zeiher, M.D., J.W. Goethe-University, Frankfurt, Germany, during the EuroPCR's late-breaking clinical trial session. The Endeavor stent is approved in more than 100 countries worldwide and currently is under review by the U.S. Food and Drug Administration. FDA approval is anticipated in the second half of 2007.

The ENDEAVOR I data continue to show excellent long-term results, with only one clinical event between years three and four, a non-cardiac death from cancer. Target Lesion Revascularization (TLR) at four years was 3.1% and Target Vessel Revascularization (TVR) was 5.2%. The Major Adverse Cardiac Event (MACE) rate, one of the trial's primary endpoints, was 7.2%, with no late stent thrombosis events in this patient cohort.

Through three years of follow-up in the ENDEAVOR II trial, the TLR rate was 7.3%, compared to 14.7% for the Driver bare metal control arm (p= less than 0.001), representing a 50% reduction in the need for repeat procedures. Target Vessel Failure, the trial's primary endpoint, was 12.8% for Endeavor and 21.4% for Driver, a 40% reduction (p= less than 0.001). Endeavor showed a MACE rate of 12.0% at three years, compared to 20.7% for Driver (p= less than 0.001), while the combined cardiac death/myocardial infarction (MI) rate for Endeavor was 4.5% and 6.7% for Driver (p=0.125). When compared to Driver, Endeavor has fewer total deaths, fewer cardiac deaths and fewer MIs at three years.

"These are well-conceived and well-managed clinical trials. The results are excellent and the clinical investigators have achieved a very admirable level of patient follow-up," said Jean Fajadet, M.D., Clinique Pasteur Unite de Cardiologie Interventionnelle, Toulouse, France, and one of the principal investigators for the ENDEAVOR II trial. "The number of repeat procedures is low, there are few adverse cardiac events and the lack of late stent thrombosis is truly extraordinary."

Using pre-specified, protocol-defined data adjudicated by the Harvard Clinical Research Institute, there have been no instances of late or very late stent thrombosis among more than 1,300 patients receiving the Endeavor stent. During the late-breaking session, Dr. Zeiher also presented Endeavor data using the broader Academic Research Consortium (ARC) definitions of stent thrombosis. Under the definitions for definite and probable stent thrombosis, Endeavor's cumulative rate in the ENDEAVOR I-III trials is 0.5% at three years and the Driver bare metal stent has a rate of 1.5%. Additionally, composite analysis of myocardial infarction and cardiac mortality showed three-year freedom from death or MI of 96.0% for Endeavor and 93.4% for the Driver bare metal stent.

"The body of data now available on Endeavor is significant and the results are impressive," said Scott Ward, senior vice president of the CardioVascular business at Medtronic. "We have made several major presentations of Endeavor data during the last year, with consistent and predictable results. Using either the pre-specified protocol definition or the new ARC definitions, these data demonstrate that Endeavor is highly effective at preventing repea t procedures without an increased safety risk, and with a favorably low incidence of death and myocardial infarction."

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.

Contact

Medtronic
Public Relations:
Yvan Deurbroeck, 41 79 249 3670
or
Scott Papillon, 707-591-7367
or
Investor Relations:
Jeff Warren, 763-505-2696


'"/>




Related medicine technology :

1. Medtronic Announces Positive Nine-Month Results for Endeavor Resolute Next Generation Drug-Eluting Stent at EuroPCR
2. Study Supports Cost-Effectiveness of Medtronics Spasticity Treatment for Children with Cerebral Palsy
3. Two-Year Results from the Medtronic ENDEAVOR III Trial Confirm Stents Positive Clinical Profile
4. Pro-Pharmaceuticals Updates Progress of Clinical Trials & Davanat 505 (b)(2) Filings
5. Avalon Updates the AVN944 Phase I Hematologic Malignancies Trial
6. NCCN Updates Esophageal and Gastric Cancer Guidelines
7. Isis Pharmaceuticals Updates Its Positive Phase 2 Data for ISIS 301012 in Familial Hypercholesterolemia Patients
8. Anesiva Announces Phase 2 Data Showing Substantial, Long-Term Pain Reductions with Adlea(TM) (formerly 4975) in Osteoarthritis of the Knee
9. Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival
10. Surfaxin (Lucinactant) Long-Term Survival Advantage vs. Comparators Published in Pediatrics
11. Long-Term Extension of Ulcerative Colitis Study Shows Remicade Responders Maintained Improvement Through Two Years of Follow-Up
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... 26, 2016 According to a new ... Market - U.S. Industry Analysis, Size, Share, Growth, Trends, and ... the U.S. was valued at US$ 5.89 Bn in 2014 ... from 2015 to 2023 to reach US$ 7.99 Bn in ... and emerging needle free drug delivery devices and the market ...
(Date:5/26/2016)... India , May 26, 2016 ... drugs market growth is the emergence of new treatments. ... astaxanthin therapies for osteoarthritis treatment. The therapy is expected ... Moreover, Arthritis Research UK is conducting studies to develop ... arcOGEN study, where the genes involved in osteoarthritis are ...
(Date:5/26/2016)... , May 26, 2016 ... Associated With Both Cost Savings and Overall ... plc (LSE: BTG), an international specialist healthcare company, ... at the 21st Annual Meeting of ISPOR (International ... treatment of hepatocellular carcinoma (HCC) using yttrium-90 glass ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... May 26, 2016 , ... Bunion Bootie , the manufacturer of ... was more than humbled by customer demand over the Mother’s Day Weekend promotion. So ... Now that Bunion Bootie has completely replenished its inventory levels, it hopes to continue ...
(Date:5/26/2016)... ... 2016 , ... The introduction of our professional athletes coincides with the company’s ... , “We are proud to introduce Meghan Klingenberg, defender and World Champion with ... wide receiver for Los Angeles who was a second round selection in the 2012 ...
(Date:5/26/2016)... , ... May 26, 2016 , ... May 2016 – ... so central to popular cosmetic improvement efforts. Record numbers of clients now ask about ... prominent or pouty, says Kally Papantoniou, MD, of Advanced Dermatology P.C. , ...
(Date:5/26/2016)... ... May 26, 2016 , ... Development Team of Pixel Film ... FCPX. , "This new layered style transition tool will keep a consistent flow to ... of Pixel Film Studios. , TranSweep is an all new layered style transition ...
(Date:5/26/2016)... ... 26, 2016 , ... According to the Webster’s dictionary, a hippie is defined ... products, one company is going against the norm with a line of all-natural skincare ... in the green space is proud to announce its latest retail partnership with the ...
Breaking Medicine News(10 mins):