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# SoniVie Breakthrough Status for Hypertension Device
- URL: https://www.fdaweb.com/sonivie-breakthrough-status-for-hypertension-device/
- Published: 2020-12-09T12:00:00.000Z
- Updated: 2026-09-14T16:39:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148261

FDA has granted SoniVie a breakthrough device designation for the Tivus System for renal artery denervation and its use in treating resistant hypertension, which is defined as blood pressure that remains above 140/90 mmHg despite use of three antihypertensive medications of different classes at the best tolerated doses, one of which must be a diuretic. The device uses high-frequency non-focused ultrasound to ablate nerves in the renal artery. “This causes a reduction in the nerve activity, which decreases blood pressure,” the company says. Previously conducted clinical trials “showed excellent feasibility in lowering blood pressure out to six months,” it adds.