Medtronic's bifurcation stent starts human trial
This article was originally published in Clinica
Executive Summary
A drug-eluting bifurcation stent could be on the horizon. Medtronic has initiated the first human trial of a non-drug-coated branched stent, results of which will determine whether it will begin developing a drug-eluting version. The safety and deliverability of the stent is being assessed in a 60-patient study called BRANCH, based in Australia and New Zealand. Primary endpoints include cardiac death, myocardial infarction involving the target vessel, and target vessel revascularisation (TVR) 30 days post-implant. Patient enrolment is expected to be complete by the end of 2008, with results available early in 2009.
You may also be interested in...
Colorado Price Cap Plan For Enbrel Draws Amgen Lawsuit; Cosentyx, Stelara ‘Affordability’ Reviews Pending
However, the state's recently formed prescription drug affordability board found Gilead’s Genvoya and Vertex’s Trikafta to be affordable.
Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations
A new memorandum by the Director of the Office of Management and Budget initiated a government-wide policy that will appoint AI officers to all agencies to address risks for AI use and serve as an example for greater AI adoption.
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.