Endeavor IV stent data
This article was originally published in The Gray Sheet
In the lead up to an Oct. 10 PMA panel review, FDA has released detailed results from Medtronic's Endeavor IV trial showing its Endeavor zotarolimus-eluting stent to be as effective as Boston Scientific's Taxus paclitaxel-eluting stent (1"The Gray Sheet" Sept. 17, 2007, p. 4). The 1,548-patient trial met its primary non-inferiority endpoint, showing target vessel failure of 6.8% at nine months, compared to 7.4% for Taxus. But it missed the secondary non-inferiority endpoint of in-segment late loss at eight months (0.36mm versus 0.23mm for Taxus) and nine-month stent thrombosis was higher for Endeavor (0.8% versus 0.1%). Endeavor's worse rates of target lesion revascularization (4.2% versus 2.7%) and target vessel revascularization (5.5% versus 5.0%) were not statistically significant. The Endeavor IV data accompanies an FDA-requested pooled data analysis from all the Endeavor studies in the Circulatory System Devices Panel materials
You may also be interested in...
Medtronic is confident being the late-comer to the U.S. drug-eluting stent market will not hinder its Endeavor zotarolimus-eluting coronary stent gaining market share
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.
Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus.