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Renal Denervation Downer: Medtronic’s Pivotal Trial Misses Efficacy Endpoint

The firm’s SYMPLICITY HTN-3 trial failed to meet its primary efficacy endpoint, scuttling Medtronic’s plans to earn a PMA for renal denervation this year. The primary investigator for the trial acknowledges in an interview that the finding raises serious questions for the future of renal denervation in hypertension.

The future of renal denervation to treat hypertension is in doubt after Medtronic PLC announced Jan. 9 that SYMPLICITY HTN-3

, the U.S. pivotal trial of the firm’s Symplicity system, missed its primary efficacy endpoint.

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