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The FDA's Circulatory System Devices Panel unanimously agreed that Medtronic's Spyral Renal Denervation device was safe, but the panel was split on its efficacy and whether its benefits outweigh the risks.
The panel voted overwhelmingly in favor of safety, but quibbled about efficacy, durability, and benefits versus risk.
The ReCor renal denervation system for treating refractory hypertension is safe and effective but further study is needed in vulnerable subpopulations, an FDA advisory panel concludes.