Externally Delivered Focused Ultrasound for Renal Denervation

JACC Cardiovasc Interv. 2016 Jun 27;9(12):1292-1299. doi: 10.1016/j.jcin.2016.04.013. Epub 2016 Jun 20.


Objectives: The aim of this study was to assess clinical safety and efficacy outcomes of renal denervation executed by an externally delivered, completely noninvasive focused therapeutic ultrasound device.

Background: Renal denervation has emerged as a potential treatment approach for resistant hypertension.

Methods: Sixty-nine subjects received renal denervation with externally delivered focused ultrasound via the Kona Medical Surround Sound System. This approach was investigated across 3 consecutive studies to optimize targeting, tracking, and dosing. In the third study, treatments were performed in a completely noninvasive way using duplex ultrasound image guidance to target the therapy. Short- and long-term safety and efficacy were evaluated through use of clinical assessments, magnetic resonance imaging scans prior to and 3 and 24 weeks after renal denervation, and, in cases in which a targeting catheter was used to facilitate targeting, fluoroscopic angiography with contrast.

Results: All patients tolerated renal denervation using externally delivered focused ultrasound. Office blood pressure (BP) decreased by 24.6 ± 27.6/9.0 ± 15.0 mm Hg (from baseline BP of 180.0 ± 18.5/97.7 ± 13.7 mm Hg) in 69 patients after 6 months and 23.8 ± 24.1/10.3 ± 13.1 mm Hg in 64 patients with complete 1-year follow-up. The response rate (BP decrease >10 mm Hg) was 75% after 6 months and 77% after 1 year. The most common adverse event was post-treatment back pain, which was reported in 32 of 69 patients and resolved within 72 h in most cases. No intervention-related adverse events involving motor or sensory deficits were reported. Renal function was not altered, and vascular safety was established by magnetic resonance imaging (all patients), fluoroscopic angiography (n = 48), and optical coherence tomography (n = 5).

Conclusions: Using externally delivered focused ultrasound and noninvasive duplex ultrasound, image-guided targeting was associated with substantial BP reduction without any major safety signals. Further randomized, sham-controlled trials will be needed to validate this unique approach.

Keywords: noninvasive; renal denervation; safety; treatment-resistant hypertension; ultrasound.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Angiography
  • Antihypertensive Agents / therapeutic use
  • Australia
  • Autonomic Denervation / instrumentation
  • Autonomic Denervation / methods*
  • Blood Pressure* / drug effects
  • Drug Resistance
  • Equipment Design
  • Europe
  • Female
  • High-Intensity Focused Ultrasound Ablation / instrumentation
  • Humans
  • Hypertension / diagnosis
  • Hypertension / physiopathology
  • Hypertension / surgery*
  • Kidney / blood supply*
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • New Zealand
  • Renal Artery / innervation*
  • Surgical Equipment
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Doppler, Duplex


  • Antihypertensive Agents