Healthcare Industry News: Zotarolimus
News Release - October 24, 2006
Data Presented by Independent Physician Panel Confirms Low Rate of Thrombosis with Medtronic Endeavor Drug-Eluting Stent
Endeavor's Low Thrombosis Rate Comparable to Bare Metal Stent StandardMINNEAPOLIS--(HSMN NewsFeed)--Medtronic (NYSE:MDT ) today announced that data reviewed by an independent physician panel - using new, broader definitions for evaluating stent thrombosis - confirms that the Endeavor® drug-eluting stent (DES) has a very low rate of stent thrombosis. The independent panel will present detailed findings of this retrospective analysis during a special drug-eluting stent safety session later today at the Cardiovascular Research Foundation's (CRF) 18th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
Specifically, the blinded, retrospective analysis shows that the Endeavor stent has an overall stent thrombosis incidence of 0.5 percent by Kaplan-Meier survival estimates to three years. This compares to 1.4 percent for the Medtronic Driver® bare metal stent. The new, independent analysis reaffirms that the Endeavor stent continues to provide an excellent DES safety profile no matter what definition is used. Under the pre-specified, prospective definitions used in Endeavor clinical trial protocols, Endeavor has an overall thrombosis rate of 0.3 percent, with zero late stent thrombosis (thrombosis occurring after 30 days of implant).
"The data on Endeavor shows that it provides the efficacy of a drug-eluting stent and the safety of a bare metal stent, dramatically reducing repeat procedures while maintaining a favorable safety profile," said Scott Ward, president of Medtronic's vascular business. "Following reports of adverse events in drug-eluting stents in early September, we voluntarily subjected our clinical data to this blinded, retrospective analysis in accordance with the new ARC definitions. We are pleased that the analysis reinforces a safety profile for Endeavor that physicians and patients can trust - under any definition of safety."
The Endeavor drug-eluting stent is in clinical investigations and not yet available in the U.S. It was approved in Europe in 2005.
The new definitions for stent thrombosis were created by the Academic Research Consortium (ARC), a group of global thought leaders made up of representatives from academia, clinical research organizations, regulatory authorities and industry. This group came together over a series of meetings during the past year to harmonize various clinical trial definitions for drug-eluting stents. These meetings produced a tiered set of definitions designed to broaden and standardize the definitions for stent thrombosis, also known as the "Dublin definitions." Using these new definitions, Medtronic's data was analyzed by an independent physician panel, as well as the Harvard Clinical Research Institute.
The Endeavor drug-eluting stent was designed for optimal clinical outcomes and has demonstrated excellent safety and sustained efficacy in approximately 1,300 Endeavor patients. In two-year follow-up of patients from the ENDEAVOR II pivotal trial, Endeavor showed a Target Lesion Revascularization (TLR) rate of 6.5 percent, and Endeavor also demonstrates an overall TLR reduction of 56 percent compared to the Driver bare metal stent. These strong outcomes stem from Endeavor's unique combination of the non-inflammatory PC Polymer, which mimics the outside surface of a red blood cell, and the powerful anti-restenotic and non-toxic drug, Zotarolimus. Together, they help promote the healthy healing of tissue around the stent following implantation.
"The clinical performance of Endeavor is now very well characterized," Ward said. "We remain on track to submit our PMA later this fall and we anticipate approval in the U.S. in mid-2007."
Medtronic Composite Analysis Also Supports Endeavor Safety Profile
Medtronic also announced the findings of a composite analysis of all cause death and Q-wave myocardial infarction (QMI) data from the ENDEAVOR I-III clinical trials. This analysis showed that Endeavor has a lower composite death/QMI rate (2.2 percent) at two years compared to the Driver bare metal stent (3.1 percent). This data provides another metric demonstrating the excellent safety profile of the Endeavor drug-eluting stent because bare metal stents have been considered by most medical experts to be the benchmark standard for safety in patients undergoing percutaneous coronary interventions. The Driver stent is widely considered to be one of the leading bare metal stents, making the reduction in death/QMI with Endeavor even more impressive.
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: In the United States, the Endeavor and Endeavor RESOLUTE
Drug-Eluting Coronary Stents are investigational devices with an investigational drug (Zotarolimus) and are 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 April 28, 2006. Actual results may differ materially from anticipated results.
Source: Medtronic
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