US FDA panel votes against use of Medtronic's blood pressure treatment device (updated)

Otsuka Holdings

23/08/2023 23:34

(Adds voting details in paragraph 3,4, background in paragraph
throughout)
       Aug 23 (Reuters) - The U.S. Food and Drug
Administration's independent experts on Wednesday narrowly voted
against recommending the approval of Medtronic's  MDT.N  blood
pressure treatment device, saying risks tied to using it do not
outweigh the benefits. 
    The same panel on Tuesday voted in favor of rival ReCor's
device for use in a surgery called renal denervation in patients
whose high blood pressure cannot be controlled by drugs. 
    When asked if the benefits outweighed the risks of the
device, six members each voted for and against it, while one
abstained. The chairperson of the panel then had to break the
tie to vote against the device.
    Separately, while all panel members voted the device was
safe to use, 6 of 13 voted against its effectiveness.
    The panel's recommendations are not binding, but are usually
followed by the FDA.  
    Medtronic did not immediately respond to a request for
comment.
    Japan-based Otsuka Holdings'  4578.T  unit ReCor's device
was shown to provide a benefit in lowering blood pressure in
clinical trials. Medtronic's device helped to lower blood
pressure at the doctor's clinic but not at home, which is
considered a more accurate measure of blood pressure monitoring.
    Medtronic and the FDA's staff reviewers said before the
meeting that additional analyses of the data showed the
difference could be due to factors such as use of more drugs by
patients treated with a "sham" procedure. 
    The company was seeking the health regulator's nod for the
device indicated for patients whose hypertension, or high blood
pressure, cannot be controlled with drugs.
    The surgery, which is allowed in Europe and other parts of
the world, is not approved in the U.S., after initial studies of
older devices used in the procedure failed key studies, and
several companies dropped out of the race to develop them.
    

 (Reporting by Sriparna Roy in Bengaluru; Editing by Krishna
Chandra Eluri)
 ((Sriparna.Roy@thomsonreuters.com;))