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Focused Ultrasound Therapy

Focused ultrasound is a rapidly evolving, 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.

How it Works
Where the beams converge, the ultrasound produces precise ablation (thermal destruction) of the nerves which cause hypertension. Much of this work has been in renal nerves, but other nerves have also been studied. 

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. Focused ultrasound is noninvasive, so it may be able to help lower blood pressure without the side effects of medication. It can also be repeated, if necessary.

Clinical Trials

A clinical trial in China is using focused ultrasound to treat the perirenal adipose tissue to reduce essential 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.

Notable Papers

Li D, Cao F, Han J, Wang M, Lai C, Zhang J, Xu T, Bouakaz A, Wan M, Ren P, Zhang S. The sustainable antihypertensive and target organ damage protective effect of transcranial focused ultrasound stimulation in spontaneously hypertensive rats. J Hypertens. 2023 May 1;41(5):852-866. doi: 10.1097/HJH.0000000000003407. Epub 2023 Mar 2. PMID: 36883470 

Ji N, Li Y, Wei J, Chen F, Xu L, Li G, Lin WH. Autonomic modulation by low-intensity focused ultrasound stimulation of the vagus nerve. J Neural Eng. 2022 Dec 16;19(6). doi: 10.1088/1741-2552/aca8cd.

Liao Q, Yang F, Xiong B, Zheng X, Wang Y, Qian J, Qiao Z, Huang J. Optimal Strategy for HIFU-Based Renal Sympathetic Denervation in Canines. Front Cardiovasc Med. 2021 Oct 14;8:739560. doi: 10.3389/fcvm.2021.739560. eCollection 2021.

Ji N, Lin WH, Chen F, Xu L, Huang J, Li G. Blood Pressure Modulation With Low-Intensity Focused Ultrasound Stimulation to the Vagus Nerve: A Pilot Animal Study. Front Neurosci. 2020 Nov 12;14:586424. doi: 10.3389/fnins.2020.586424. eCollection 2020.

Xue Q, Wang R, Wang L, Xiong B, Li L, Qian J, Hao L, Wang Z, Liu D, Deng C, Rong S, Yao Y, Jiang Y, Zhu Q, Huang J. Downregulating the P2 × 3 Receptor in the Carotid Body to Reduce Blood Pressure via Acoustic Gene Delivery in Canines. Transl Res. 2020 Jun 14:S1931-5244(20)30145-6. doi: 10.1016/j.trsl.2020.06.005.

Li D, Cui Z, Xu S, Xu T, Wu S, Bouakaz A, Wan M, Zhang S. Low-intensity focused ultrasound stimulation treatment decreases blood pressure in spontaneously hypertensive rats. IEEE Trans Biomed Eng. 2020 Feb 20. doi: 10.1109/TBME.2020.2975279.

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.

Click here for additional references from PubMed.

International Approval
Clinical Trials