Renal Denervation Downer: Medtronic’s Pivotal Trial Misses Efficacy Endpoint
This article was originally published in The Gray Sheet
The firm’s SYMPLICITY HTN-3 trial failed to meet its primary efficacy endpoint, scuttling Medtronic’s plans to earn a PMA for renal denervation this year. The primary investigator for the trial acknowledges in an interview that the finding raises serious questions for the future of renal denervation in hypertension.
You may also be interested in...
FDA has set a panel meeting date in December that will include discussion of trial designs and potential indications for devices being developed to treat hypertension. Also, the advisory panel will look at an implantable device seeking approval for use in heart-failure patients.
Certain VCs are becoming reluctant to invest in medtech, citing difficulties such as a shrinking pool of buyers and increasing regulatory challenges. But Sofinnova Partners has successfully sold a medical device portfolio company – and one that is in a difficult field like renal denervation, no less – to a Japanese buyer. Antoine Papiernik, managing partner at the French VC, explains how persevering with a renal denervation technology paid-off and gives his perspective on whether medtech is still a space worth investing in.
Medtronic is re-upping its investments into renal denervation to treat hypertension after interim results were positive from a study testing the device procedure in patients not taking antihypertensive drugs. The firm announced it is launching a new pivotal study, more than three-and-a-half years after its last pivotal trial in the space failed.