Medtronic Receives Regulatory Approval For Endeavor(R) Drug-Eluting Coronary Stent In Japan

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 01 Apr 2009 - 1:00 PDT

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Medtronic, Inc. (NYSE: MDT), announced approval of its Endeavor drug-eluting coronary stent system by the Japanese Ministry of Health, Labor and Welfare (MHLW), clearing the way for the highly anticipated launch of the product in the world's second largest market for advanced medical technology.

Medtronic plans to launch the Endeavor drug-eluting stent (DES) immediately following the authorization of reimbursement which is expected on May 1. Following the launch in Japan, the Endeavor DES will be commercially available for the treatment of coronary artery disease in every major market in the world. The Endeavor DES provides the reassurance of long‐term safety and durable efficacy in the treatment of coronary artery disease.

"The large and growing body of evidence from clinical studies and clinical practice around the world continues to demonstrate the enduring benefits of the Endeavor stent for patients with coronary artery disease," said Sean Salmon, vice president of Medtronic CardioVascular and general manager of Medtronic's Coronary and Peripheral business. "We look forward to bringing these benefits to Japan very soon."

The robust ENDEAVOR clinical program has demonstrated that the Endeavor DES is associated with exceptionally low rates of stent thrombosis, myocardial infarction (MI) and cardiac death, as well as low rates of clinically‐driven target lesion revascularization (TLR), out to as long as five years of patient follow‐up. Representing various world geographies (including Japan) and patient subsets, the program has enrolled more than 10,000 subjects to date and will ultimately enroll more than 20,000 subjects in a combination of randomized controlled and single‐arm trials.

ENDEAVOR Japan (n=99), a single‐arm trial of Japanese subjects with a primary endpoint of TVF at nine months, reflects the consistent results of the ENDEAVOR clinical program overall and contributed to the regulatory approval of the Endeavor DES in Japan. At two years, the TVF rate in ENDEAVOR Japan was 8.7 percent, comparable to the same measure in other trials of the Endeavor DES, and there have been no instances of definite/probable stent thrombosis (early, late or very late), with predictably low rates of death (2.2 percent) and MI (2.2 percent).

The Endeavor DES received the CE (Conformité Européene) mark in August 2005 and was approved by the U.S. Food and Drug Administration (FDA) in February 2008. It is part of Medtronic's broad coronary stents portfolio, which provides physicians with choices to address the spectrum of clinical needs.

About Medtronic

Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world.

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Medtronic