FDA Panel Narrowly Votes Against Use Of Medtronic's Blood Pressure Treatment Device

(RTTNews) - The U.S. Food & Drug Administration Circulatory System Devices Panel narrowly voted against recommending approval of Medtronic plc.'s (MDT) blood pressure treatment device.

The company noted that members of the FDA's Panel voted fully in support of Medtronic Symplicity Spyral Renal Denervation System's safety (13-0), with a close vote in support of effectiveness (7-6) but a tie regarding benefits versus risk (6-6). One member abstained. The chairperson of the panel broke the tie with his vote of no.

The panel recommendation will be considered by the FDA as it continues to review the Medtronic Symplicity Spyral Renal Denervation System for U.S. market approval.

According to the company, the Medtronic Symplicity Spyral renal denervation system uses a minimally invasive procedure that delivers radiofrequency energy to specific nerves near the kidneys that can become overactive and cause high blood pressure. Approved for commercial use in 70 countries around the world, the Symplicity Spyral Renal Denervation System is currently limited to investigational use in the U.S., Japan, and Canada.

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