US FDA staff raise no concerns about Otsuka, Medtronic blood pressure devices

Otsuka Holdings

18/08/2023 19:21

Aug 18 (Reuters) - The U.S. Food and Drug Administration
(FDA) staff reviewers said on Friday they found no safety and
effectiveness issues with devices made by Otsuka Holdings
 4578.T  and rival Medtronic Plc  MDT.N  for use in a blood
pressure treatment surgery.
    The FDA staff's assessment comes ahead of meetings of two
independent expert panels next week, where they will make
recommendations on whether or not to approve the devices for
treatment. 
    The surgery, known as renal denervation, is allowed in
Europe and other parts of the world, but is not yet approved in
the U.S., after initial studies of older devices used in the
procedure failed key trials.
    The staff reviewers said the available safety data for the
device made by ReCor, a unit of Otsuka Holdings, did not raise
concerns, while pointing that there was limited long-term data.
There was no specific comment on Medtronic's device.
    ReCor's device, 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. 
    On the other hand, Medtronic's device is a spiral shaped
catheter and generator combination that uses targeted
radiofrequency energy to destroy select nerves.
    The devices are meant for patients whose hypertension, or
high blood pressure, cannot be controlled with drugs. 
    These devices have successfully met the main goal of
reducing blood pressure as their makers re-designed their trials
and reconstituted their patient groups after earlier tests
failed. Details on the patient group were not available.
    Needham analysts expect the devices might see limited sales
for the first few years as the companies take time to build a
market. 
    According to Medtronic, the market size could reach $500
million by 2026 and $2 billion to $3 billion by 2030.
    The FDA advisers will meet on Tuesday to discuss ReCor's
device and convene the day after to deliberate on rival
Medtronic's equipment. 

 (Reporting by Sriparna Roy in Bengaluru
Editing by Vinay Dwivedi)
 ((Sriparna.Roy@thomsonreuters.com;))