US FDA panel backs Otsuka’s blood pressure treatment device

Aug 22 (Reuters) – A panel of U.S. Food and Drug Administration (FDA) advisers on Tuesday recommended the use of a device made by a unit of Otsuka Holdings (4578.T) in a type of surgery to treat high blood pressure.

The FDA panel voted 10 to 12 backing the use of the device made by the Japanese company’s unit ReCor for renal denervation, a surgery in which nerve endings in the kidney are disrupted in an effort to lower blood pressure.

All 12 panel members voted unanimously in favor of the safety of the device.

Eight of the panel members voted in favor of the device’s effectiveness, while three voted against it. One abstained.

The surgery, which is allowed in Europe and other parts of the world, is not approved in the United States, after initial studies of older devices used in the procedure failed key studies.

Newer devices including those from ReCor and rival Medtronic (MDT.N) have successfully helped to reduce blood pressure through the renal denervation surgery, in large studies.

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 company is seeking for the approval of the device indicated for use in patients whose hypertension, or high blood pressure, cannot be controlled with drugs.

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