New Data from ENDEAVOR-II Challenges Conventional Wisdom on Drug-Eluting Stents

* Reuters is not responsible for the content in this press release.

Tue May 19, 2009 10:02am EDT

Five-Year Results Confirm Durability of Endeavor Stent`s Long-Term Clinical
Efficacy
BARCELONA, Spain--(Business Wire)--
New clinical data presented today at a major international meeting of
interventional cardiologists challenged the conventional wisdom on the long-term
efficacy of drug-eluting stents, medical devices used in the treatment of
coronary artery disease. 

In ENDEAVOR-II (n=1,197), a randomized controlled trial comparing Medtronic`s
(NYSE:MDT) Endeavor drug-eluting stent (DES) to its Driver bare-metal stent
(BMS), patients treated with the Endeavor DES required fewer repeat procedures
at five years post-implant than many observers and analysts would have expected
based on the results of other trials with comparable designs. 

With clinical data from ENDEAVOR-II now through five years of follow-up, the
Endeavor DES continues to show a distinctively low and durable plateau in the
rate of target lesion revascularization (TLR), a standard measure of efficacy
for coronary stents. As presented today at EuroPCR09 in a late-breaking clinical
trials session by Dr. David Kandzari of the Scripps Clinic in La Jolla, Calif.,
the TLR rate in this seminal DES trial at five years is 7.5 percent, only a 0.3
percent difference from the rate at three and four years. 

"The long-term performance of the Endeavor stent is really remarkable," said Dr.
Kandzari. "There is an especially unique consistency and durability in late-term
TLR that is distinct from alternative DES programs." 

Safety has long been the Endeavor stent`s hallmark, with exceptionally low rates
of complications including very late stent thrombosis to five years across
various geographies, patient subsets and trial designs. These latest results
confirm that the Endeavor stent`s long-term safety is complemented by long-term
efficacy. 

"The Endeavor stent continues to distinguish itself with a strong record of
sustained safety and clinical efficacy," said Sean Salmon, vice president and
general manager of Medtronic CardioVascular`s Coronary and Peripheral business.
"From preclinical research and clinical imaging studies, we believe that the
Endeavor stent`s proven biocompatibility contributes to complete and functional
healing early on and positive long-term outcomes for patients." 

This long-term data also will be submitted in a pre-market approval (PMA)
application for review by the U.S. Food and Drug Administration. 

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. 

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 25, 2008. Actual results may differ materially from anticipated results.





Medtronic, Inc.
Public Relations:
Joe McGrath, 707-591-7367
or
Investor Relations:
Jeff Warren, 763-505-2696 



Copyright Business Wire 2009

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.