Product Name:  Endeavor ABT-578-eluting stent

Description:    •  A cobalt-based alloy stent coated with a phosphorylcholine (PC) polymer and ABT-578. Company:    •  Medtronic, Inc. General Modality:    •  Medical Devices Specific Modality:    • Stents General Product Type:    •  Drug-Eluting Specific Product Type:    •  Antiproliferative-eluting Stents Clinical Trials:    •  ENDEAVOR I - The Clinical Evaluation of the MEdtroNic AVE ABT-578 Coated DrivEr Coronary Stent in De Novo NAtiVe COronary ARtery Lesions    •  ENDEAVOR II - A Randomized Controlled Trial to Evaluate the Safety and Efficacy of the MEdtroNic AVE ABT-578 Eluting DrivEr Coronary Stent in De Novo NAtVe COronary ARtery Lesions    •  ENDEAVOR III - The Clinical Evaluation of the MEdtroNic AVE ABT-578 Coated DrivEr Coronary Stent in De Novo NAtiVe COronary ARtery Lesions    •  ENDEAVOR IV - The Clinical Evaluation of the MEdtroNic AVE ABT-578 Coated DrivEr Coronary Stent in De Novo NAtiVe COronary ARtery Lesions **Please Note: All links will open in the current window - to open a link in a new window please right click the link and select "Open in New Window" or "Open in New Tab"		Commercial Approval:    • Awarded a CE Mark July 2005 Development Status - Clinical Trials:    • ENDEAVOR IV will be a randomized trial at an estimated 70 U.S. sites comparing the Endeavor stent to the Taxus stent.  In April 2005 the first patient was implanted in the 1,548-patient study.  TVF at 9 months is the primary endpoint and MACE at 30 days is a secondary endpoint in this trial.    • The 100-patient ENDEAVOR I clinical trial is being conducted in Australia and New Zealand to test the ABT-578 coated Driver stent system in single de novo lesions (≤15 mm in length and diameter between 3.0 and 3.5mm). (November 2003) Results are pending as of 2004.    • The 1,200 patient ENDEAVOR II trial is over half completed and is designed to demonstrate safety and efficacy of the Driver stent coated with 10 mcg/mm ABT-578 compared to the uncoated Driver stent. The test will be conducted in patients with de novo coronary lesions (2.25-3.5mm in diameter, 14-27mm in length). Results are pending as of 2004. 8 and 9-month clinical results from the ENDEAVOR II trial are expected to be announced at the ACC meeting in March 2005.    • ENDEAVOR III will be a randomized trial that will include 436 patients and compare the Endeavor stent to the Cypher stent. Enrollment was completed in September 2004.
Comments:    • Medtronic plans on a European launch in late 2004 and a release in the U.S. a year later. (November 2003)    • Medtronic expects a U.S. release of the Endeavor DES by early 2006. (October 2004) Last Update: December 6, 2007

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