Medtronic Completes PMA Application For Symplicity Spyral Hypertension Device
The six-month results from SPYRAL HTN ON MED trial of Medtronic’s Symplicity Spyral renal denervation system did not meet its primary endpoint, but the company and analysts expect the FDA will still approve Symplicity Spyral as the first renal denervation system available in the US to treat uncontrolled hypertension.
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News We're Watching: Renal Denervation Trial Highlights, TAP Pilot Update, Cardiohelp Safety Alert
Two new studies support ReCor’s Radiance Ultrasound Renal Denervation System, and renal denervation also won the backing of European medical societies. Additionally, the FDA issued an update on the Total Product Life Cycle Advisory Program (TAP) “soft” pilot, and a disposable component of the Getinge/Maquet Cardiohelp system was flagged for possible sterility issues.
Cardio Catch-Up: Medtronic, Recor, Pulnovo Report Progress On Denervation To Treat Hypertension
The late-breaking clinical trial presentations at this year’s Transcatheter Cardiovascular Therapeutics conference in Boston included new results from trials of three different minimally invasive approaches to treat uncontrolled hypertension.
Finding A Future For Renal Denervation With Better Controlled Trials
Minimizing the variability in patient attributes and procedural techniques will be crucial to future renal denervation trials having a chance at success, experts suggested last month at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C.