(Reuters) – The U.S. Food and Drug Administration on Friday approved the use of Medtronic’s treatment device in a surgery called renal denervation in patients whose high blood pressure cannot be controlled by drugs, the company said.
The agency’s decision is in contrast with the recommendation of a panel of independent experts, who narrowly voted against allowing the use of the device in August.
All members of the advisory panel had voted that the device was safe to use, but six of 13 panelists had voted against its effectiveness.
Medtronic said it will immediately begin commercialization of its device, known as Symplicity.
The device helps deliver a type of electromagnetic radiation to overactive nerves near the kidneys that contribute to high blood pressure through a minimally invasive procedure.
The approval comes days after the health regulator allowed use of a rival device called Paradise Ultrasound Renal Denervation, made by Japanese company Otsuka’s unit ReCor.
Initial studies of older devices used in the surgery failed key studies, and several companies dropped out of the race to develop them. Newer devices including those from ReCor and Medtronic have successfully helped to reduce blood pressure through renal denervation surgery, in large studies.
The procedure has previously been allowed in Europe and other parts of the world.
(Reporting by Bhanvi Satija in Bengaluru; Editing by Chris Reese)
