Medtronic Launches U.S. Trial of CoreValve Evolut R TAVR
This article was originally published in The Gray Sheet
The recaptureable system will be evaluated in 250 patients considered at high or extreme risk for open-heart surgery.
You may also be interested in...
The market opportunity for TAVR is significant, with 2013 sales totaling $303.4 million in the US and $765 million outside the US, and those numbers are expected to grow to an estimated $1.29 billion and $1.63 billion, respectively, by 2018. Edwards and Medtronic dominate the worldwide market at present, but other companies are expected to make inroads with next-generation devices designed to optimize outcomes.
In 14-6 vote, advisory committee said use of external control comparison to contextualize single-arm trial data demonstrated efficacy and reliance on preclinical data as confirmatory evidence was justified.
A selective androgen receptor modulator also being studied in metastatic breast cancer, enobosarm might offer potential as add-on therapy to GLP-1 agonists prescribed for weight loss, the Miami biotech asserts.