FDA Panel Supports Otsuka and ReCor's Blood Pressure Treatment Devices
A panel of advisers to the US FDA has recommended the use of a blood pressure treatment device made by Otsuka Holdings' unit, ReCor, for renal denervation surgery. The device, which sends ultrasound energy to burn nerves that control blood pressure, was unanimously backed for safety by all 12 panel members, with eight voting in favor of its effectiveness. The panel recommended the device as a possible add-on therapy to reduce blood pressure, not as a replacement for medications. If approved, ReCor plans to initiate a post-market study registry to evaluate the long-term data of the surgical device.