Medtronic says Endeavor stent shows consistent clinical efficacy, strong safety profile

By Elaine Rigoli

Tampa, Fla., March 14 - Medtronic, Inc. released updated results from the Endeavor 3 confirmatory U.S. trial and pooled data from 1,300 patients across four global clinical studies that provided further evidence that the Endeavor stent is deliverable, effective and safe in treating patients with coronary artery disease, according to a company news release.

"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, in a statement.

"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 4 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 of 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.

Pooled data from Endeavor 1, 2 and 3 trials (including Endeavor 2 continued access) 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 release said.

The updated Endeavor 3 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 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).

The pooled data also 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, the release said.

Medtronic, based in Minneapolis, develops medical technology for alleviating pain and restoring health.

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