What happened
Shares of Medtronic (MDT 0.62%) fell 3.1% on Thursday, according to data provided by S&P Global Market Intelligence, giving back yesterday's post-earnings gains after it announced advisors to the U.S. Food and Drug Administration (FDA) had a mixed reaction to its investigational renal denervation system, Symplicity Spyral.
So what
In a press release yesterday, Medtronic announced the U.S. FDA's Circulatory System Devices Panel (CSDP) committee voted unanimously (13-0) on the device's safety and narrowly voted in favor (7-6) of the effectiveness of the Symplicity blood pressure procedure. At the same time, however, the committee also narrowly voted against the benefit/risk profile of the device (6-7).
Now what
Multiple analyst firms weighed in today following the FDA's seemingly lukewarm votes: Needham analysts argued that the FDA is unlikely to approve the device given the votes, while Raymond James analysts suggested Medtronic "will ultimately get FDA approval for the device, although the label may be narrower than anticipated."
Of course, Medtronic would have preferred a more overwhelmingly positive outcome from FDA's CSDP votes, but we can be sure the company will continue to move forward with its attempts to get Symplicity Spyral approved.
"We appreciate the robust conversation that occurred prior to the vote," stated Medtronic Senior VP and President of the Coronary and Renal Denervation business, Jason Weidman. "We will continue to collaborate with the FDA on bringing a new option to the millions of people living with high blood pressure."
