Medtronic Announces Regulatory Approval in China for the Endeavor® Drug-Eluting Coronary Stent System
MINNEAPOLIS – June 21, 2006 – Medtronic, Inc. (NYSE: MDT) today announced that it has received regulatory approval from the government of the People’s Republic of China to begin selling the Endeavor® drug-eluting coronary stent (DES) system in that country. China is one of the fastest growing vascular markets in the world and one of the largest DES markets in Asia at more than $100 million. Approximately 70,000 drug-eluting stents are implanted each year in China.
“The most important thing for patients is a successful outcome of the procedure,” said Prof. Dr. Ge, Zhong Shan Hospital and Co-Chairman of the Shanghai Institute of Cardiovascular Diseases. “Evidence from the Endeavor clinical trials and from commercial use around the world has confirmed excellent outcomes for patients. The number of times patients are required to return for repeat procedures is low and there also is a low rate of clinically adverse complications.”
In May, Medtronic presented data at the Paris Course on Revascularization that provided clinical evidence demonstrating the long-term safety and efficacy of the Endeavor stent. In addition to low rates of repeat procedures, the three-year and two-year results from the ENDEAVOR I and ENDEAVOR II clinical trials demonstrated low rates of major adverse events such as death and myocardial infarction. There also was no late stent thrombosis reported in either of the two trials. Endeavor patients who participated in the trials for at least one year, there have been no reported cases of late stent thrombosis, which is the formation of dangerous blood clots that potentially can lead to heart attacks or death. “The Endeavor stent is proven to be safe and effective, and it is among the most deliverable DES products on the market,” said Max Muhs, vice president of Medtronic’s vascular business in China. “We believe it offers the best combination of features among the drug-eluting stents available in Asia, and we are pleased to bring Endeavor to the physicians and patients in China. This further strengthens our commitment in China, following the recent opening of our world-class physician training center in Beijing.”
Made of a cobalt alloy and built on the same platform as the popular Medtronic Driver® bare metal stent, the Endeavor drug-eluting stent has a unique modular architecture designed to enhance deliverability. In the ongoing Medtronic “e-FIVE” international post-market patient registry, physicians have had a 99.5 percent success rate in delivering the Endeavor stent. In addition to the drug compound zotarolimus (ABT-578), Endeavor is coated with phosphorylcholine, a polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane, leading to an ideal healing response.
With regulatory approval now granted in China and the recent announcement of reimbursement in France, the Endeavor drug-eluting coronary stent is commercially available in approximately 100 countries worldwide. The Endeavor stent is not yet approved for use in the United States, but Medtronic filed its first Pre-Market Approval (PMA) module with the U.S. Food and Drug Administration in October 2005 and the company remains on track for PMA approval in calendar year 2007. The stent received CE Mark approval in July 2005.
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 (zotarolimus, ABT-578) and exclusively for clinical investigation.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Quarterly Report on Form 10-Q for the quarter ended January 27, 2006. Actual results may differ materially from anticipated results.
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