Medtronic shares fall after FDA advisors’ lukewarm vote on blood-pressure treatment device

Medtronic PLC shares
MDT,
-0.05%
were down 1.3% premarket on Thursday after advisors to the U.S. Food and Drug Administration had a mixed reaction to the company’s investigational renal denervation system, used to treat high blood pressure. In a close vote, the advisory committee said the benefits of the system, Symplicity Spyral, did not outweigh the risks, although the panel voted favorably on the system’s safety and effectiveness. Advisory committee votes are not binding. But “given the vote, we think that the FDA is unlikely to approve Symplicity Spyral,” Needham analysts wrote in a note Thursday. Other analysts saw a more positive outcome. Raymond James analysts said in a note late Wednesday that they still believe Medtronic will ultimately get FDA approval for the device, although the label may be narrower than anticipated. “We appreciate the robust conversation that occurred prior to the vote,” Medtronic senior vice president Jason Weidman said in a statement. “We will continue to collaborate with the FDA on bringing a new option to the millions of people living with high blood pressure.” Medtronic shares have gained 7.7% in the year to date, while the S&P 500
SPX,
+1.10%
has gained 15.5%.