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Medtronic receives FDA approval for renal denervation device

The company received approval for the hypertension treatment despite a mixed vote from an FDA advisory panel.

Medtronic received approval from the Food and Drug Administration for its Symplicity Spyral renal denervation device, the second device of its kind to be authorized by the agency.
An FDA advisory panel in August found the risks outweighed the benefits of Medtronic’s blood-pressure treatment but voted in favor of its safety and efficacy.
The decision follows approval of a competing device made by Recor Medical earlier this month. Medtronic said it plans to immediately begin commercialization.

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Medtronic’s Symplicity Spyral device uses radiofrequency energy delivered through a catheter to destroy overactive nerves near the kidney to lower blood pressure. With the approval, the device will be available as an adjunctive treatment for patients where lifestyle modifications and anti-hypertensive medications did not adequately control their blood pressure.

“This landmark approval is the culmination of rigorous scientific study and clinical trials, including long-term, sham-controlled studies in the presence and absence of medication, and the largest real-world study,” David Kandzari, co-principal investigator of the SPYRAL clinical program and chief of the Piedmont Heart Institute, said in a statement by Medtronic.

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