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Sustained Safety Profile of Medtronic's Endeavor Drug-Eluting Stent Differentiates It from Other DES

WASHINGTON--(BUSINESS WIRE)--Oct 14, 2008 - The latest update to an independently conducted pooled data analysis shows once again how the Endeavor drug-eluting stent (DES) from Medtronic, Inc. (NYSE: MDT), is distinguished by persistently strong safety benefits for patients with coronary artery disease. Called ENDEAVOR-Safety, the analysis now includes more than 1,100 patients followed to four years.

Compared to a bare-metal stent (n=596), the Endeavor DES (n=2,132) has been shown at four years to be associated with numerically lower rates of death, cardiac death, major adverse cardiac events (MACE), myocardial infarction (MI) and stent thrombosis, with the differences in rates of cardiac death and MI between the two devices reaching statistical significance in this retrospective analysis. The results, released today at the Transcatheter Cardiovascular Therapeutics (TCT) meeting and summarized below, also include a comparison of stent thrombosis in Endeavor patients receiving six and 12 months of dual antiplatelet therapy.

Dr. Laura Mauri, chief scientific officer of the Harvard Clinical Research Institute, an interventional cardiologist at Brigham and Women's Hospital Boston and principal author of the ENDEAVOR-Safety analysis, said: "These data are truly remarkable when you remember that we're not comparing Endeavor to another DES but to a bare-metal stent. The stent thrombosis figures alone present a compelling case. Despite more than 70 percent of Endeavor patients being off dual-antiplatelet therapy at 12 months, the cumulative incidence of ARC-defined (Academic Research Consortium) stent thrombosis at four years is only 0.7%, almost half the rate observed for the bare-metal stent (1.5 percent (p=0.071))."

"Even more reassuringly with Endeavor," Dr. Mauri added, "almost all of these events occurred in the first 360 days. Such a predictable freedom from very late events - again, numerically lower than the bare-metal stent - inspires confidence when we can expect our patients to live many years with the stents we implant."

Sean Salmon, vice president and general manager of the Coronary and Peripheral Vascular business at Medtronic, commented: "The latest update to this four-year safety analysis provides physicians with the reassurance that really matters to patients - long-term freedom from adverse events and long-term freedom from repeat procedures. Interestingly, Endeavor's safety profile appears to be unaffected by differences in duration of dual-antiplatelet therapy." -0-

                       ENDEAVOR-Safety Analysis
      Cumulative Incidence (%) of Safety Endpoints to 1,440 Days
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Endpoint                    Endeavor DES             Driver BMS
                              n=2,132                  n=596
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Death                           5.1                     5.2
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Cardiac Death                   1.9                     2.6
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MI                              2.9                     4.4
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Cardiac Death/MI                4.6                     7.0
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Stent Thrombosis
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-- protocol                     0.5                     1.2
----------------------------------------------------------------------
-- ARC def/prob                 0.7                     1.5
----------------------------------------------------------------------

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.

Contact

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

 

Posted: October 2008

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