Although unanimously endorsing the safety of Medtronic’s Symplicity Spyral Multi-electrode Renal Denervation system, members of the FDA’s Circulatory System Devices Panel were split on both the efficacy and risk/benefit balance of the ultrasound-powered device, intended to treat hypertension by ablating sympathetic nerves in the renal arteries.

After reviewing two sham-controlled trials — one marginally positive and one negative — the 13-member panel voted 7-6 that the device offered a “reasonable assurance” of efficacy in the target population. But Chairman Richard Lange cast the deciding negative vote in a 6-6 tie (with one abstention) on whether its benefits outweigh its risks.

“We're facing the negative trial unfortunately,” said Lange of Texas Tech University Health Sciences Center, El Paso. “We can try to explain it away but, in the end, it's a negative trial. And so I can't honestly look patients in the eye and tell them that I believe that the benefit outweighs the risks.”

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