US FDA panel backs Otsuka's blood pressure treatment device (updated)

Otsuka Holdings

22/08/2023 23:16

(Adds details on votes in paragraphs 3 and 4, background
throughout)
       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.
  

 (Reporting by Sriparna Roy in Bengaluru; Editing by Maju
Samuel)
 ((Sriparna.Roy@thomsonreuters.com;))