Home Diseases and Conditions Atherosclerosis

Atherosclerosis

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Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound for this condition has been researched in clinical trials. However, at this time, we are not aware of any open clinical trials.

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with atherosclerosis. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. Where the beams converge, the ultrasound produces a variety of biological effects enabling atherosclerosis to be treated without surgery. While significant preclinical work has been accomplished, there is still much to be done before this technology will be widely available.

How it Works
The mechanism of action is to use focused ultrasound to disrupt or fracture the atherosclerotic plaques that exist within the arteries of patients.

Advantages
The primary options for treatment of atherosclerosis include medication, minimally invasive procedures and major surgery. For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost.  Focused ultrasound can reach the desired target without damaging surrounding tissue, and it can be repeated, if necessary.

Clinical Trials

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of atherosclerosis.

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/

See a list of laboratory research sites >

Find a Treatment Site

Search for a treatment center or clinical trial near you.

Regulatory Approval and Reimbursement

Focused ultrasound treatment for atherosclerosis is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Hu H, Wu H, Zhu T, Cheng Y, Guo W, Tan T, Hu C, Jiang H, Wang S. Long-term transcranial ultrasound stimulation regulates neuroinflammation to ameliorate post-myocardial infarction cardiac arrhythmia and remodeling. Heart Rhythm. 2025 Sep;22(9):2418-2429. doi: 10.1016/j.hrthm.2024.10.017. Epub 2024 Oct 15. PMID: 39413944 

Samaddar A, Adhikari P, Wang D, Wu S, Wang J, Forrest ML, Yang X. An In Vivo Study on the Feasibility of Catheter-Assisted Pulsed Focused Ultrasound Ablation of Atherosclerotic Plaques. Ultrasound Med Biol. 2025 Jul 18:S0301-5629(25)00220-0. doi: 10.1016/j.ultrasmedbio.2025.06.021. PMID: 40683822 

Yuan S, Hu J, Xia C, Li Q, Li C. Thermal therapy of atherosclerotic plaques using ultrasonic phased-array system. Med Biol Eng Comput. 2025 Jul 16. doi: 10.1007/s11517-025-03407-w. PMID: 40668349 

Wiggers RBM, Groen MHA, de Borst GJ, Ebbini E, Grünhagen T, van Es R, Doevendans PAFM, Hazenberg CEVB. First in Human Use of Non-invasive, Robot Assisted, High Intensity Focused Ultrasound Treatment of Femoral Atherosclerosis: A Safety and Feasibility Pilot Study. Eur J Vasc Endovasc Surg. 2025 Jun 20:S1078-5884(25)00565-9. doi: 10.1016/j.ejvs.2025.06.038. PMID: 40545124 

Zhang Q, Cai Q, Zhong S, Li Q, Qiu W, Wu J. Vagus Nerve Stimulation by Focused Ultrasound Attenuates Acute Myocardial Ischemia/Reperfusion Injury Predominantly Through Cholinergic Anti-inflammatory Pathway. Cardiovasc Drugs Ther. 2025 Jun 2. doi: 10.1007/s10557-025-07718-w. PMID: 40455110 

Lei W, Hu J, Zhai J, Gong J, Tian F, Chang S, Zou X, Ju F, Qian S. Study of heat transfer and flow within atherosclerotic plaques in a focused ultrasound field. Ultrasonics. 2025 May 15;154:107699. doi: 10.1016/j.ultras.2025.107699. PMID: 40393268 

Yan X, Yue K, Zhang X, Yuan C, Wang H. Numerical analysis of heat transfer and hemodynamics in inhibition of stent restenosis by high intensity focused ultrasound hyperthermia. J Therm Biol. 2025 Jun 9;131:104172. doi: 10.1016/j.jtherbio.2025.104172. PMID: 40513361 

Ma Z, Li M, Guo R, Tian Y, Zheng Y, Huang B, You Y, Xu Q, Cui M, Shen L, Lan F, Yang H, Liu R, Yang T, Wan F, He Q, Huo X, Bi Y, Zhang Y, Ling Y. Treating myocardial infarction via a nano-ultrasonic contrast agent-mediated high-efficiency drug delivery system targeting macrophages. Sci Adv. 2025 Jan 3;11(1):eadp7126. doi: 10.1126/sciadv.adp7126. PMID: 39752485 

An H, Qiu X, Wang X, Du C, Guo X, Hou S, Xu M, Wang J, Cheng C, Ran H, Li P, Wang Z, Zhou Z, Ren J, Jiang W. LIFU-unlocked endogenous H2S generation for enhancing atherosclerosis-specific gas-enzymatic therapy. Biomaterials. 2024 Nov 22;315:122972. doi: 10.1016/j.biomaterials.2024.122972. PMID: 39591768 

Yu C, Zhong L, Zhou Y, Jiang N, Chen J, Cao S. Identification of the Vulnerability of Atherosclerotic Plaques by a Photoacoustic/Ultrasonic Dual-Modal cRGD Nanomolecular Probe. Int J Nanomedicine. 2024 Sep 11;19:9395-9410. doi: 10.2147/IJN.S476236. eCollection 2024. PMID: 39282572 

Samaddar A, Singh R, Yang X, Ebersole KC, Forrest ML. Investigating the potential of catheter-assisted pulsed focused ultrasound ablation for atherosclerotic plaques. Med Phys. 2024 Aug;51(8):5181-5189. doi: 10.1002/mp.17253. Epub 2024 Jun 14. PMID: 38873842 

Zhang C, Wu Y, Zhang Q, Zhang M, Zhang D. The impact of ischemic vascular stenosis on LIPU hyperthermia efficacy investigated Based on in vivo rabbit limb ischemia model. Ultrasonics. 2024 Feb 10;138:107263. doi: 10.1016/j.ultras.2024.107263. PMID: 38350312 

Nie C, A R, Wang J, Pan S, Zou R, Wang B, Xi S, Hong X, Zhou M, Wang H, Yu M, Wu L, Sun X, Yang W. Controlled Release of Hydrogen-Carrying Perfluorocarbons for Ischemia Myocardium-Targeting 19 F MRI-Guided Reperfusion Injury Therapy. Adv Sci (Weinh). 2023 Aug 18:e2304178. doi: 10.1002/advs.202304178.

Imtiaz C, Farooqi MA, Bhatti T, Lee J, Moin R, Kang CU, Farooqi HMU. Focused Ultrasound, an Emerging Tool for Atherosclerosis Treatment: A Comprehensive Review. Life (Basel). 2023 Aug 21;13(8):1783. doi: 10.3390/life13081783.

Kim H, Wu H, Chen M, Dai X, Zhou R, Jiang X. Intravascular Sono-Ablation for In-Stent Restenosis Relief: Transducer Development and the In-Vitro Demonstration. IEEE Trans Biomed Eng. 2023 Jul;70(7):2172-2180. doi: 10.1109/TBME.2023.3238679. Epub 2023 Jun 19. PMID: 37022452 
 
Click here for additional references from PubMed.