FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
The U.S. Food and Drug Administration (FDA) approved the use of a device made by an Otsuka Holdings unit in a type of surgery to treat high blood pressure, the company said on Wednesday.
The approval for Paradise Ultrasound Renal Denervation comes after an FDA panel backed its use.
The device is made by Japanese company Otsuka’s unit ReCor and is indicated for use in patients whose hypertension, or high blood pressure, cannot be controlled with drugs.
ReCor’s device, which is a balloon-like structure inside a catheter, is inserted through a small cut into the kidney’s arteries and sends ultrasound energy to burn nerves that are believed to control blood pressure.
The surgery has been previously approved in Europe and other parts of the world.