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Medtronic dips after FDA panel votes against use of hypertension treatment device

Published 08/24/2023, 09:43 AM
Updated 08/24/2023, 09:33 AM

Investing.com -- Shares in Medtronic PLC (NYSE:MDT) fell in early trading on Thursday after a regulatory panel in the U.S. voted against recommending the use of its blood pressure treatment device.

The independent expert panel of the Food and Drug Administration (FDA) said that the risks of utilizing the company's Symplicity Spyral Renal Denervation System outweighed its benefits. Minnesota-based Medtronic's device aims to help patients with hypertension who cannot be aided by drugs.

But its benefits were subject to deep debate, with six members of the FDA's Circulatory System Devices Panel each voting for and against it. Only a vote by the panel's chairperson broke the deadlock.

Seven of the 13 members voted in favor of the procedure's effectiveness, while all the members voted that it was safe to use.

The FDA is not obligated to follow the panel's decision, although it rarely chooses not to listen to its advice.

In a statement, Jason Weidman, senior vice president of Medtronic's Coronary and Renal Denervation business,  said that it will continue to collaborate with the FDA on developing a new option.

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