ESC 2017: Renal-Denervation Redux? Medtronic Plans A New Pivotal Study Following Positive Data
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.
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US FDA has approved Medtronic's plan for the SPYRAL HTN Pivotal Trial, part of the SPYRAL HTN Global Clinical Program. SPYRAL HTN is a multi-phased clinical study strategy to establish the safety and efficacy of renal denervation with the Symplicity Spyral system to reduce blood pressure in patients with uncontrolled hypertension. The Spyral device and procedure, as well as the design of the SPYRAL HTN clinical trial, reflect lessons learned from SYMPLICITY HTN-3, the first sham-controlled trial of renal denervation, which famously failed to show a benefit of the procedure.
Starts & Stops is a regular feature highlighting Medtech Insight's monthly picks of noteworthy clinical trial announcements, initiations, completions, and suspensions. The list for December is headlined by announcements on Edwards' transcatheter valve technologies. Meanwhile, MValve, a company Boston Scientific has invested in, is not going forward with a planned trial of its MValve dock device with Boston Scientific's Lotus valve, which is currently off the market.
More details about the controversial ORBITA trial.