Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Canada approves Endeavor

This article was originally published in The Gray Sheet

Executive Summary

Health Canada's Therapeutic Products Directorate approves Medtronic's Endeavor zotarolimus-eluting coronary stent, the firm announces March 26. The approval was based on seven studies with a total of 4,100 patients followed up to four years. As a condition of approval, the company will submit to Health Canada annual updates on its 5,000-patient post-market trial, as well as other studies investigating the risk of stent thrombosis, myocardial infarction and optimal dual anti-platelet therapy. Medtronic launched Endeavor in Europe in 2005 and began U.S. marketing Feb. 1 following FDA approval (1"The Gray Sheet" Feb. 4, 2008, In Brief)

You may also be interested in...



Endeavor drug-eluting stent approved

Medtronic launches its Endeavor zotarolimus-eluting stent immediately upon FDA approval Feb. 1, and expects to ship 100,000 units to U.S. hospitals in the next 30 days. Endeavor is the first drug-eluting stent approved in nearly four years and the third DES on the U.S. market. Device industry analysts expect Endeavor to take 15%-20% of the near $2 billion U.S. DES market. As conditions of approval, Medtronic will conduct a 2,000-patient U.S. post-approval study, to be combined with data from 3,300 patients outside the U.S., as well as continue to follow patients in six Endeavor trials for five years. Abbott's Xience everolimus-eluting stent, also up for FDA approval this year, got a positive recommendation from an FDA advisory committee in November (1"The Gray Sheet" Dec. 3, 2007, p. 3)

Basilea Stresses Derazantinib's FGFR Kinase Differentiation

Switzerland’s SIX exchange-listed drug development company, Basilea, is moving two new oncology candidates along its R&D pipeline, supported by strong revenues from two partnered anti-infective products.

 

ATMPs Put EU Cross-Border Healthcare On The Map

Recommendations from the Alliance for Regenerative Medicine aim to improve cross-border healthcare to ensure patients can access advanced therapies.

UsernamePublicRestriction

Register

MT025934

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel