Focused Ultrasound Therapy
Focused ultrasound is an early-stage, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with hypertension. This novel technology focuses beams of ultrasonic energy precisely and accurately on renal nerves without damaging surrounding normal tissue. Where the beams converge, the ultrasound produces precise ablation (thermal destruction of tissue) enabling hypertension to be treated without surgery.
The primary options for treatment of hypertension include medication, but many have side effects which limit therapy effectiveness.
For certain patients, focused ultrasound could provide a noninvasive and potentially more effective alternative to current medical management.
Researchers at the Chongqing Medical University initially investigated the feasibility of noninvasive focused ultrasound in controlling blood pressure through renal denervation in preclinical studies. Subsequent clinical studies with US guided focused ultrasound for renal denervation show promising results. Three single-arm pilot studies sponsored by Kona Medical reveal a 23% decrease in systolic blood pressure on average.
- Focused ultrasound is noninvasive, so it may be able to help lower blood pressure without the side effects of medication.
- Focused ultrasound may have better compliance than repeated.
- It can be repeated, if necessary.
At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of hypertension.
Regulatory Approval and Reimbursement
Focused ultrasound treatment for hypertension has the CE Mark in Europe. It has not been approved by the FDA and is not covered by medical insurance companies in the US.
Schmieder RE1, Ott C, Toennes SW, Bramlage P, Gertner M, Dawood O, Baumgart P, O'Brien B, Dasgupta I, Nickenig G, Ormiston J, Saxena M, Sharp ASP, Sievert H, Spinar J, Starek Z, Weil J, Wenzel U, Witkowski A, Lobo MD. Phase II randomized sham-controlled study of renal denervation for individuals with uncontrolled hypertension - WAVE IV. J Hypertens. 2017 Oct 13. doi: 10.1097/HJH.0000000000001584.
Schmieder RE, Ott C, Bramlage P. Non-invasive Renal Denervation: Update on External Ultrasound Approaches. Curr Hypertens Rep. 2016 Jun;18(6):48. doi: 10.1007/s11906-016-0653-6.
Rong S, Zhu H, Liu D, Qian J, Zhou K, Zhu Q, Jiang Y, Yang G, Deng C, Zhang D, Zhou Q, Lei H, He TC, Wang Z, Huang J. Noninvasive renal denervation for resistant hypertension using high-intensity focused ultrasound. Hypertension. 2015 Oct;66(4):e22-5. doi: 10.1161/HYPERTENSIONAHA.115.05754. Epub 2015 Aug 3.
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