(Reuters) -The U.S. Food and Drug Administration’s (FDA) independent experts on Wednesday narrowly voted against recommending the approval of Medtronic’s 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.
“We appreciate the robust conversation that occurred prior to the vote,” Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business, Medtronic, said in a statement, adding, the company will continue to collaborate with the FDA on bringing a new option.
Japan-based Otsuka Holdings’ 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 and Rashmi Aich)
