www.fdanews.com/articles/72874-medtronic-provides-update-on-endeavor-stent-program
Medtronic Provides Update on Endeavor Stent Program
June 1, 2005
Medtronic has received an update regarding the status of its application for CE mark approval of its Endeavor drug-eluting coronary stent.
Medtronic was informed by European regulatory authorities that the device portion of the review has been completed, but that regulatory authorities have issued a few clarifying questions about the drug used to coat the experimental Endeavor stent. The drug compound, ABT-578, is made by Abbott Laboratories.
The company anticipates CE mark approval upon the resolution of these few remaining regulatory questions. The European regulatory authorities did not provide a specific timeline for completing their final review.