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Medtronic’s Endeavor™ Stent Continues to Show Consistent Clinical Efficacy and Strong Safety Profile |
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15 Mar 2006 |
Endeavor on Track for U.S. Approval in 2007; ENDEAVOR IV Enrollment Nears 1,000 Patients
MINNEAPOLIS, MN, USA | Mar 14, 2006 | The Medtronic Endeavor™ drug-eluting coronary stent system continues to demonstrate both consistent clinical efficacy and a strong safety profile, according to new data presented today at the American College of Cardiology (ACC) 55th Annual Scientific Session in Atlanta. Updated results from the ENDEAVOR III confirmatory U.S. trial and pooled data from 1,300 patients across four global clinical studies provide further evidence that Endeavor stent is deliverable, effective and safe in treating patients with coronary artery disease.
“The clinical performance of Endeavor is well-characterized in our four clinical trials,” said Scott Ward, Medtronic senior vice president and president of Medtronic Vascular. “With each milestone that we pass, we continue to see consistency between each trial and across various patient subsets within each trial, as well as an ongoing safety profile that remains truly remarkable.”
Medtronic also reported that the ENDEAVOR IV trial – a head-to-head confirmatory trial against the Boston Scientific Taxus stent – has enrolled nearly 1,000 patients and is on pace to complete full enrollment (1,548 patients) this spring. The trial has a primary endpoint of Target Vessel Failure at nine months and is the fourth in a series of trials that will provide efficacy and safety data on more than 2,000 total Endeavor patients. Medtronic (NYSE: MDT) remains on track for a PMA submission timetable and regulatory schedule that should lead to U.S. commercial approval in 2007.
At ACC, Medtronic (NYSE: MDT) provided 12-month results from the ENDEAVOR III study and pooled safety and efficacy data on more than 1,300 patients from the ENDEAVOR I, II, and III trials (including Endeavor II Continued Access). The pooled data confirms Endeavor’s excellent safety record, with no observations of late stent thrombosis (more than 30 days after implant), and an overall thrombosis rate of just 0.3%.
The updated ENDEAVOR III data also showed that safety and clinical efficacy for Endeavor was maintained at 12 months, with no statistically significant difference in any clinical endpoint for either Endeavor or the Johnson & Johnson Cypher stent between nine and 12 months. For example, Target Vessel Failure (TVF) rates for the two stents at 12 months were 13.2% for Endeavor and 11.8% for Cypher (p = 0.87), compared with 12.0% and 11.5% respectively at nine months (p = 1.00).
Other pooled data demonstrated no significant differences in TLR or late loss across high risk subgroup parameters, such as vessel diameter size, lesion length and patient diabetic status. In addition, the pooled data showed that the highly deliverable Endeavor stent had a device success rate of 99.2%.
The Endeavor system received CE Mark approval in July 2005 and has been launched in more than 85 countries internationally, with approval expected in other key countries later this year. Medtronic will present additional Endeavor data at the Paris Course on Revascularization (PCR) in May, including three-year results from ENDEAVOR I and two-year results from ENDEAVOR II.
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. |
