STAT+: FDA panel votes against high blood pressure device from Medtronic, but lends support to ReCor Medical’s
An FDA advisory panel delivered a split decision on a surgical system used in a controversial blood pressure treatment called renal denervation.
An advisory panel to the Food and Drug Administration delivered a split decision on a surgical system used in a controversial blood pressure treatment called renal denervation.
The panel, whose advice the FDA typically follows, voted that the system developed by ReCor Medical was safe and effective. It voted that the benefits of a system developed by Medtronic, however, did not outweigh the risks.
“While this is a very safe procedure, the efficacy was mild at best,” Keith Allen, director of surgical research at St. Luke’s Hospital of Kansas City, said regarding Medtronic’s device.
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