Focused ultrasound is a rapidly evolving, therapeutic technology that could transform the quality of life and decrease the cost of care for patients with various types of cardiomyopathy. The initial work was done on hypertrophic cardiomyopathy, but as this approach, if successful could help with other forms, this is an exciting possibility for many types of cardiomyopathy. Another approach is using Low Intensity Pulsed Ultrasound on an animal model, to impact the ischemic cardiomyopathy. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

How it Works 
Where the beams converge, focused ultrasound produces an expanded importation of CRISPR-Cas9 adenovirus ribonucleoprotein into human pluripotent stem cells. To say this in a simpler format, focused ultrasound enables the ability to genetically edit the target cells to be better able to accomplish their tasks. The LIPUS treatment was preventative and alleviated ventricular remodeling, improved electrophysiological function and decreased the release of inflammatory cytokines.  

The primary options for treatment of cardiomyopathy are limited, and often include medications which can have adverse side effects.  

While significant work has been accomplished, there is still much to be done before this technology will be widely available. 

Advantages 

• Focused ultrasound is non-invasive, so it does not carry added concerns like surgical wound healing or infection.  

• Focused ultrasound can reach the desired target without damaging surrounding tissue. 

• It can be repeated, if necessary. 

Clinical Trials 

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

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/. 

Regulatory Approval and Reimbursement  

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

Notable Papers 

Wang C, Cheng H, Dong X, Zhan Y, Liu Y, Wu N, Tang R, He H, Cao Y, Yang L, Ren J, Li X, Li P. Early assessment and treatment of ventricular remodeling in vivo via a targeted ultrasonic molecular probe loaded with oxygen and cholecystokinin. J Nanobiotechnology. 2025 Feb 12;23(1):104. doi: 10.1186/s12951-025-03183-7. PMID: 39939853 

Owusu-Yaw BS. Focused-ultrasound-mediated CRISPR-Cas9 gene editing in human induced pluripotent stem cells. Mol Ther. 2025 Feb 20:S1525-0016(25)00096-6. doi: 10.1016/j.ymthe.2025.02.006. PMID: 39983712 

Lin ZH, Yu QL, Yi BH, Xu WC, He HL, Huang KY, Zheng C, Wu SJ, Lin JF Protective Effects of Low-Intensity Pulsed Ultrasound on Cardiac Electrophysiological Function in a Rat Model of Ischemic Cardiomyopathy. J Am Heart Assoc. 2025 Feb 14:e037402. doi: 10.1161/JAHA.124.037402. Online ahead of print. PMID: 39950540  

Hazel K, Singh D, He S, Guertin Z, Husser MC, Helfield B. Focused ultrasound and microbubble-mediated delivery of CRISPR-Cas9 ribonucleoprotein to human induced pluripotent stem cells. Mol Ther. 2025 Jan 10:S1525-0016(25)00017-6. doi: 10.1016/j.ymthe.2025.01.013. Online ahead of print. PMID: 39797397 

Gumusgoz E, Kasiri S, Youssef I, Verma M, Chopra R, Villarreal Acha D, Wu J, Marriam U, Alao E, Chen X, Guisso DR, Gray SJ, Shah BR, Minassian BA. Focused ultrasound widely broadens AAV-delivered Cas9 distribution and activity. Gene Ther. 2025 Feb 1. doi: 10.1038/s41434-025-00517-w. Online ahead of print. PMID: 39893321 

Ge N, Liu M, Li R, Allen NM, Galvin J, Shen S, O’Brien T, Prendiville TW. Using Ribonucleoprotein-based CRISPR/Cas9 to Edit Single Nucleotide on Human Induced Pluripotent Stem Cells to Model Type 3 Long QT Syndrome (SCN5A^±). Stem Cell Rev Rep. 2023 Nov;19(8):2774-2789. doi: 10.1007/s12015-023-10602-5. Epub 2023 Aug 31. PMID: 37653182  

Click here for additional references from PubMed.   

Focused ultrasound is a rapidly evolving, therapeutic technology that could transform the quality of life and decrease the cost of care for patients novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

How it Works 
Where the beams converge, focused ultrasound produces a neuromodulatory effect on the splenic tissue, resulting in significant reductions (25-30%) in the pulmonary hypertension numbers compared to the animal controls.  While significant work has been accomplished, there is still much to be done before this technology will be widely available. 

The primary options for treatment of pulmonary hypertension include medication, but the side effects of these drugs can also be limiting in its effectiveness.   

For certain patients, focused ultrasound could provide a more effective and lower cost alternative to conventional therapy.  

Advantages 

• Focused ultrasound is non-invasive, so it does not carry added concerns like surgical wound healing or infection.
• Focused ultrasound can reach the desired target without damaging surrounding tissue.
• It can be repeated, if necessary.

Clinical Trials

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

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/. 

Regulatory and Reimbursement

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

Notable Papers

Rafikova O, James J, Kudryashova TV. EnFUSiasm for Healing: Ultrasound Neuromodulation in PAH. Circ Res. 2024 Jun 21;135(1):57-59. doi: 10.1161/CIRCRESAHA.124.324791. Epub 2024 Jun 20. PMID: 38900858  

Zafeiropoulos S, Ahmed U, Bekiaridou A, Jayaprakash N, Mughrabi IT, Saleknezhad N, Chadwick C, Daytz A, Kurata-Sato I, Atish-Fregoso Y, Carroll K, Al-Abed Y, Fudim M, Puleo C, Giannakoulas G, Nicolls M, Diamond B, Zanos S. Ultrasound Neuromodulation of an Anti-Inflammatory Pathway at the Spleen Improves Experimental Pulmonary Hypertension. Circ Res. 2024 May 7. doi: 10.1161/CIRCRESAHA.123.323679. PMID: 38712557 

Click here for additional references from PubMed.   

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 varicose veins. This novel technology focuses beams of ultrasound energy precisely and accurately on targets in the body without damaging surrounding normal tissue.

How it Works
Where the beams converge, the focused ultrasound produces precise ablation (thermal destruction) of the varicose vein. This enables varicose veins to be treated noninvasively.

Advantages
The primary options for treatment of varicose veins are surgery, sclerotherapy, intravenous laser therapy, or radio frequency closure techniques.

For certain patients, focused ultrasound could provide a noninvasive alternative to these techniques with less risk of neurologic problems, phlebitis, wound issues, or other complications. It also requires no intravenous catheters, surgery, or anesthesia and can be repeated as needed.

Clinical Trials

A clinical trial using the Sonoblate High Intensity Focused Ultrasound system is recruiting patients with chronic venous incompetence for treatment.

A multi-site clinical trial testing the Sonovein system for treatment of greater saphenous vein disease has been completed. 

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/. 

Find a Treatment Site

Search for a treatment center or clinical trial near you.

Regulatory Approval and Reimbursement

Theraclion’s Echopulse has achieved the CE Mark in Europe for its SONOVEIN® system after successful clinical trials.

Focused ultrasound treatment for varicose veins is not yet approved by regulatory bodies in the US or covered by medical insurance companies.

Notable Papers

Chabouni S, Kashi M, Chauvel O, Dakhil B, Zaimi R, Pons JL, Bagan P. Assessing the effectiveness and safety of high-intensity focused ultrasound in treating venous insufficiency using a hemodynamic approach. Phlebology. 2026 Jan 21:2683555261418961. doi: 10.1177/02683555261418961. PMID: 41563076 

Casoni P, Nanni E, Pizzamiglio M, Bissacco D. High intensity focused ultrasound in treating incompetent perforator veins. Phlebology. 2025 Dec;40(10):793-799. doi: 10.1177/02683555251338767. Epub 2025 Apr 27. PMID: 40289404 

Pichot O, Ganeau A, Combes P, Millet C, Derangère V, Lafon C. Non thermal HIFU treatment for vein occlusion: Histological evidence from a pre-clinical animal study. Phlebology. 2025 Nov 28:2683555251400570. doi: 10.1177/02683555251400570. PMID: 41316803 

Rodríguez Carvajal R, Ruales Romero A, Láinez Rube R, Hernández Carbonell T. Extra-Corporeal thermal ablation with High Intensity Focused Ultrasound for superficial venous insufficiency: Preliminary results at twelve months follow-up. Phlebology. 2025 Oct;40(9):702-712. doi: 10.1177/02683555251333010. Epub 2025 Apr 15. PMID: 40233498 

Casoni P, Bissacco D, Pizzamiglio M, Nanni E. High intensity focused ultrasound in treating great saphenous vein incompetence: Perioperative and 1-year outcomes. Phlebology. 2024 Apr 1:2683555241243161. doi: 10.1177/02683555241243161. PMID: 38560785 

Obermayer A, Aubry JF, Barnat N. Extracorporeal Treatment with High Intensity Focused Ultrasound of an Incompetent Perforating Vein in a Patient with Active Venous Ulcers. EJVES Vasc Forum. 2020 Dec 5;50:1-5. doi: 10.1016/j.ejvsvf.2020.11.005. eCollection 2021.

Barnat N, Grisey A, Gerold B, Yon S, Anquez J, Aubry JF. Vein wall shrinkage induced by thermal coagulation with high-intensity-focused ultrasound: numerical modeling and in vivo experiments in sheep. Int J Hyperthermia. 2020;37(1):1238-1247. doi: 10.1080/02656736.2020.1834626.

Whiteley MS. High intensity focused ultrasound (HIFU) for the treatment of varicose veins and venous leg ulcers – a new non-invasive procedure and a potentially disruptive technology. Curr Med Res Opin. 2019 Dec 6:1-4. doi: 10.1080/03007995.2019.1699518.

Barnat N, Grisey A, Lecuelle B, Anquez J, Gerold B, Yon S, Aubry JF. Noninvasive vascular occlusion with HIFU for venous insufficiency treatment: preclinical feasibility experience in rabbits. Phys Med Biol. 2019 Jan 7;64(2):025003. doi: 10.1088/1361-6560/aaf58d.

Click here for additional references from PubMed.

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 ventricular tachycardia. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. While there are many forms of cardiac arrythmia, the majority of this work has been done on ventricular tachycardia so far.

How it Works
Where the beams converge, focused ultrasound can produce precise ablation (thermal destruction) of the malfunctioning tissue that is causing the ventricular tachycardia. Another option is to ablate the stellate ganglion, as this elevates the threshold for ventricular fibrillation. Both of these steps are accomplished noninvasively. These preclinical projects have been recently accomplished, but it will take further studies before clinical use can occur.

Advantages
The primary options for treatment of ventricular tachycardia include medication and invasive surgical procedures.

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 also 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 ventricular tachycardia.

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/. 

Regulatory Approval and Reimbursement

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

Notable Papers

Xiang C, Cheng Y, Yu X, Mao T, Luo H, Hu H, Wu Y, Sang R, Wang Z, Wang Y, Luo Q, Huang J, Zhao J, Wang J, Wang X, Chen M, Liu W, Zhou L, Wang S, Jiang H. Low-intensity focused ultrasound modulation of the paraventricular nucleus to prevent myocardial infarction-induced ventricular arrhythmia. Heart Rhythm. 2023 Nov 30:S1547-5271(23)02976-4. doi: 10.1016/j.hrthm.2023.11.026. PMID: 38042443 

Wang S, Li B, Li X, Wu L, Zhu T, Zhao D, Jiang H. Low-intensity ultrasound modulation may prevent myocardial infarction induced sympathetic neural activation and ventricular arrhythmia. J Cardiovasc Pharmacol. 2020 Feb 17. doi: 10.1097/FJC.0000000000000810.

Yao Y, Qian J, Rong S, Huang Y, Xiong B, Yang G, Zhang D, Deng S, Tan J, Zhu Q, Deng C, Liu D, Ran H, Wang Z, Huang J. Cardiac Denervation for Arrhythmia Treatment with Transesophageal Ultrasonic Strategy in Canine Models. Ultrasound Med Biol. 2019 Feb;45(2):490-499. doi: 10.1016/j.ultrasmedbio.2018.10.013. Epub 2018 Dec 6.

Lü F, Huang W, Benditt DG. A feasibility study of noninvasive ablation of ventricular tachycardia using high-intensity focused ultrasound. J Cardiovasc Electrophysiol. 2018 May;29(5):788-794. doi: 10.1111/jce.13459. Epub 2018 Mar 6.

Click here for additional references from PubMed.

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 mitral regurgitation (MR). This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.

How it Works
Where the beams converge, the focused ultrasound produces precise ablation (thermal destruction) of the central basal chordae, a structure which normally supports the mitral valve but can result in regurgitant blood flow after an infarction. The planned result is that cutting this structure can improve the function of the mitral valve. This work has been done in a preclinical setting, but further research will be needed before it is available for treating humans.

Advantages
The primary options for treatment of MR includes medication or invasive surgical procedures.

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. The noninvasive approach can be especially valuable since the patients may have recently had a myocardial infarction. Focused ultrasound can also 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 MR.

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/. 

Regulatory Approval and Reimbursement

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

Notable Papers

Villemain O, Kwiecinski W, Bel A, Robin J, Bruneval P, Arnal B, Tanter M, Pernot M, Messas M. Pulsed cavitational ultrasound for non-invasive chordal cutting guided by real-time 3D echocardiography. Eur Heart J Cardiovasc Imaging. 2016 Oct;17(10):1101-7. doi: 10.1093/ehjci/jew145. Epub 2016 Aug 12.

Abe Y, Otsuka R, Muratore R, Fujikura K, Okajima K, Suzuki K, Wang J, Marboe C, Kalisz A, Ketterling JA, Lizzi FL, Homma S. In vitro mitral chordal cutting by high intensity focused ultrasound. Ultrasound Med Biol. 2008 Mar;34(3):400-5. Epub 2007 Nov 7.

Click here for additional references from PubMed.

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 peripheral artery disease (PAD). This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.

How it Works
There are several mechanisms of action that are being explored. Mechanical fractionation of clots and ultrasound-enhanced delivery of drugs to treat the disease are both being investigated as potential new therapies. Another approach is to use low-intensity focused ultrasound prior to the infusion of autologous Adipose Derived Stem Cells to promote their adherence and function in patients with severe peripheral arterial disease. This approach showed safety and vascular improvement in a small number of patients.

Advantages
The primary options for treatment of PAD include medication and invasive 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 also reach the desired target without damaging surrounding tissue, and it can be repeated, if necessary.

Clinical Trials

Much of the work on PAD is preclinical, and there is a completed clinical trial looking to expand the arterial blood flow in compromised regions.  

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 here for a list of treatment sites >
See here for a list of laboratory research sites >

Regulatory Approval and Reimbursement

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

Notable Papers

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 Oct;70(4):492-499. doi: 10.1016/j.ejvs.2025.06.038. Epub 2025 Jun 20. PMID: 40545124 

Skoog P, Nordanstig J. Challenging the Peripheral Arterial Disease Treatment Paradigm: A Novel Therapeutic Approach that Awaits Definitive Clinical Validation. Eur J Vasc Endovasc Surg. 2025 Oct;70(4):500-501. doi: 10.1016/j.ejvs.2025.06.077. Epub 2025 Jul 5. PMID: 40618989 

Mohamad Yusoff F, Kajikawa M, Yamaji T, Kishimoto S, Maruhashi T, Nakashima A, Tsuji T, Higashi Y. Low-intensity pulsed ultrasound improves symptoms in patients with Buerger disease: a double-blinded, randomized, and placebo-controlled study. Sci Rep. 2024 Jun 14;14(1):13704. doi: 10.1038/s41598-024-64118-0. PMID: 38871832  

Groen MHA, Slieker FJB, Vink A, de Borst GJ, Simons MV, Ebbini ES, Doevendans PA, Hazenberg CEVB, van Es R. Safety and feasibility of arterial wall targeting with robot-assisted high intensity focused ultrasound: a preclinical study. Int J Hyperthermia. 2020;37(1):903-912. doi: 10.1080/02656736.2020.1795278.

Wong, Rodriguez-Araujo, Cawich et al. First in Human Phase I/Phase II Safety and Preliminary Efficacy Study Using Low Frequency Ultrasound in Addition to Adipose Derived Stem Cells in Patients with Moderate to Severe Lower Extremity Peripheral Arterial Disease. Abstract to the American Society of Gene and Cell Therapy, April 2019. Item 93.

Click here for additional references from PubMed.

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 the need for septal perforation. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.

How it Works
Where the beams converge, the focused ultrasound produces precise ablation (thermal or mechanical destruction) of tissue enabling the septum to be perforated without surgery.

Pilot clinical research has demonstrated the potential of focused ultrasound to accurately and repeatedly create focal perforations in atrial tissue without direct contact. Aside from its thermal ablative effects, focused ultrasound is also capable of precise mechanical tissue destruction through a process known as histotripsy. A preclinical study has already demonstrated the ability of histotripsy to noninvasively create an atrial septal defect in a canine model.

Advantages
The primary options for treatment of those who need septal perforation include minimally invasive 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 also 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 septal perforation.

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 here for a list of laboratory research sites >

Regulatory Approval and Reimbursement

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

Notable Papers

Jang KW, Tu TW, Nagle ME, Lewis BK, Burks SR, Frank JA. Molecular and histological effects of MR-guided pulsed focused ultrasound to the rat heart. J Transl Med. 2017 Dec 13;15(1):252. doi: 10.1186/s12967-017-1361-y.

Zheng M, Shentu W, Chen D, Sahn DJ, Zhou X. High-intensity focused ultrasound ablation of myocardium in vivo and instantaneous biological response. Echocardiography. 2014 Oct;31(9):1146-53. doi: 10.1111/echo.12526.

Alkins R, Huang Y, Pajek D, Hynynen K. Cavitation-based third ventriculostomy using MRI-guided focused ultrasound. J Neurosurg. 2013 Dec;119(6):1520-9. doi: 10.3171/2013.8.JNS13969.

Miller RM, Kim Y, Lin KW, Cain CA, Owens GE, Xu Z. Histotripsy cardiac therapy system integrated with real-time motion correction. Ultrasound Med Biol. 2013 Dec;39(12):2362-73. doi: 10.1016/j.ultrasmedbio.2013.08.004. Epub 2013 Sep 21.

Click here for additional references from PubMed. 

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 hypertension. This novel technology focuses beams of ultrasonic energy precisely and accurately on renal nerves or other nervous tissues 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. Another way being pursued is to use barbiturate loaded nanoparticles, which in animal models can enhance the GABA pathway and improve hypertension control.

Advantages
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

There is one clinical trial in Nanjing that is treating patients with hypertension. 

There is a clinical trial in Suzhou that is treating patients with hypertension. 

There is a clinical trial in Guangdong, China that is treating patients with hypertension. 

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/.  

Find a Treatment Site

Search for a treatment center or clinical trial near you.

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

Cordeanu EM, Morisot E, Bronner F, Prinz E, Stephan D. From resistant hypertension to renal denervation: an emerging therapeutic approach in light of new international guidelines. Int J Cardiol Cardiovasc Risk Prev. 2025 Nov 17;27:200550. doi: 10.1016/j.ijcrp.2025.200550. eCollection 2025 Dec. PMID: 41333717 

Lopez AF, Routkevitch D, Kramer PJ, Babu NA, Jillala R, Tandri A, Soulé Z, Baca EC, Davidar AD, Vattipally VN, Perkins PL, Krishnan S, Bohluli RS, Eberhart CG, Tyler BM, Theodore N, Thakor NV, Manbachi A. Spinal cord neuromodulation for blood pressure control using low-intensity focused ultrasound. Sci Rep. 2025 Nov 21;15(1):41363. doi: 10.1038/s41598-025-25330-8. PMID: 41272077 

Zheng X, Rong S, Liao Q, Fang Q, Wang X, Lou Y, Li Q, Qian J, Wang J, Wang Y, Zhao X, Xiong B, Wang L, Li H, Yao Y, Zhu Q, Jiang Y, Yang G, Xiao L, Ma C, Huang J. Renal denervation guided and ablated by noninvasive ultrasound in canines. Ultrasonics. 2025 Sep;153:107666. doi: 10.1016/j.ultras.2025.107666. Epub 2025 Apr 16. PMID: 40262440 

Lea-Banks H, Chauhan N, Hynynen K. Investigating the hypotensive effect of focused ultrasound neuromodulation and barbiturate-loaded nanodroplets in healthy and hypertensive rats. Brain Stimul. 2024 Nov-Dec;17(6):1317-1327. doi: 10.1016/j.brs.2024.12.002. Epub 2024 Dec 4.PMID: 39643112  

Jiang X, Yu W, Chen Z, Li C, Li X, Xu Y, Li F, Gao H, Qian J, Xiong B, Rong S, Chen G, She Q, Huang J. Low-intensity focused ultrasound combined with microbubbles for non-invasive downregulation of rabbit carotid body activity in the treatment of hypertension. Hypertens Res. 2024 Nov;47(11):3182-3192. doi: 10.1038/s41440-024-01904-3. Epub 2024 Sep 19. PMID: 39300302 

Takei Y. Downregulation of carotid body activity using low-intensity focused ultrasound: a potential treatment option for refractory hypertension. Hypertens Res. 2024 Oct 28. doi: 10.1038/s41440-024-01977-0. PMID: 39468315 

Jiang X, Yu W, Chen Z, Li C, Li X, Xu Y, Li F, Gao H, Qian J, Xiong B, Rong S, Chen G, She Q, Huang J. Low-intensity focused ultrasound combined with microbubbles for non-invasive downregulation of rabbit carotid body activity in the treatment of hypertension. Hypertens Res. 2024 Sep 19. doi: 10.1038/s41440-024-01904-3. PMID: 39300302 

Camafort M, Ihm SH, Ruilope LM. Renal denervation for the treatment of hypertension and kidney disease. Curr Opin Nephrol Hypertens. 2023 Nov 1;32(6):544-550. doi: 10.1097/MNH.0000000000000928. Epub 2023 Sep 13. PMID: 37706512 

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 

Click here for additional references from PubMed.

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 hypoplastic left heart syndrome. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. 

How it Works
Where the beams converge, the focused ultrasound produces precise ablation (either thermal or mechanical destruction of tissue) which produces an atrial septal defect. This allows pulmonary venous blood returning to the left heart to be shunted to the right heart, which improves blood flow.

An important treatment component is ensuring adequate patency of an atrial septal defect which allows pulmonary venous blood returning to the left heart to be shunted to the right heart. Focused ultrasound is capable of precise mechanical tissue destruction through a process known as histotripsy, and a preclinical study has already demonstrated the ability of histotripsy to noninvasively create an atrial septal defect.

Advantages
The primary options for treatment of hypoplastic left heart syndrome are surgical.

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 for certain aspects of treatment. Focused ultrasound can also 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 hypoplastic left heart syndrome.

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/. 

Regulatory Approval and Reimbursement

Focused ultrasound treatment for hypoplastice left heart syndrome is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Villemain O, Kwiecinski W, Bel A, Robin J, Bruneval P, Arnal B, Tanter M, Pernot M, Messas E. Pulsed cavitational ultrasound for non-invasive chordal cutting guided by real-time 3D echocardiography. Eur Heart J Cardiovasc Imaging. 2016 Oct;17(10):1101-7. doi: 10.1093/ehjci/jew145. Epub 2016 Aug 12.

Devanagondi R1, Zhang X2, Xu Z3, Ives K4, Levin A5, Gurm H6, Owens GE7. Hemodynamic and Hematologic Effects of Histotripsy of Free-Flowing Blood: Implications for Ultrasound-Mediated Thrombolysis. J Vasc Interv Radiol. 2015 Oct;26(10):1559-65. doi: 10.1016/j.jvir.2015.03.022. Epub 2015 May 4.

M. Azmin, C. Harfield, Z. Ahmad, M. Edirisinghe, and E. Stride, “How do microbubbles and ultrasound interact? Basic physical, dynamic and engineering principles.,” Curr. Pharm. Des., vol. 18, no. 15, pp. 2118–2134, 2012.

Owens GE, Miller RM, Owens ST, Swanson SD, Ives K, Ensing G, Gordon D, Xu Z. Intermediate-term effects of intracardiac communications created noninvasively by therapeutic ultrasound (histotripsy) in a porcine model. Pediatr Cardiol. 2012 Jan;33(1):83-9. doi: 10.1007/s00246-011-0094-6. Epub 2011 Sep 11. PubMed PMID:21910018.

Xu Z, Owens G, Gordon D, Cain C, Ludomirsky A. Noninvasive creation of an atrial septal defect by histotripsy in a canine model. Circulation. 2010 Feb16;121(6):742-9. doi: 10.1161/CIRCULATIONAHA.109.889071. Epub 2010 Feb 1. PubMed PMID: 20124126; PubMed Central PMCID: PMC2834201.

W. W. Roberts, T. L. Hall, K. Ives, J. S. Wolf Jr., J. B. Fowlkes, and C. A. Cain, “Pulsed cavitational ultrasound: A noninvasive technology for controlled tissue ablation (histotripsy) in the rabbit kidney,” J. Urol., vol. 175, no. 2, pp. 734–738, 2006.

Click here for additional references from PubMed. 

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 extravascular hematomas. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the brain without damaging surrounding normal tissue.

How it Works
Where the beams converge, the focused ultrasound produces histotripsy (mechanical destruction) of the fibers within the hematoma. This enables the hematoma to be aspirated with fine needle instead of requiring a surgical removal. While early results are promising, there is still much to be done before this technology will be widely available.

Advantages
The primary options for treatment of hematomas include medication and invasive 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 also 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 extravascular hematomas.

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/. 

Regulatory Approval and Reimbursement

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

Notable Papers

Gong L, Wright AR, Hynynen K, Goertz DE. Histotripsy of blood clots within hollow cylindrical transducers for aspiration thrombectomy applications. Ultrasound Med Biol. 2026 Mar 17:S0301-5629(26)00072-4. doi: 10.1016/j.ultrasmedbio.2026.02.016. PMID: 41850958 

Ri J, Xu L, Shang L, Yue X, Greenwald SE, Mohammed M, Shen L. Investigation of Thrombolysis and Safety of Stand-Alone High-Intensity Focused Ultrasound Therapy in Partially Occluded Ex-Vivo Animal Models. Ultrasound Med Biol. 2025 Jul 21:S0301-5629(25)00216-9. doi: 10.1016/j.ultrasmedbio.2025.06.017. PMID: 40695687 

Ponomarchuk EM, Rosnitskiy PB, Tsysar SA, Khokhlova TD, Karzova MM, Kvashennikova AV, Tumanova KD, Kadrev AV, Buravkov SV, Trakhtman PE, Starostin NN, Sapozhnikov OA, Khokhlova VA. Elastic Properties of Aging Human Hematoma Model In Vitro and Its Susceptibility to Histotripsy Liquefaction. Ultrasound Med Biol. 2024 Jun;50(6):927-938. doi: 10.1016/j.ultrasmedbio.2024.02.019. Epub 2024 Mar 20. PMID: 38514363 

Tam A, Contreras K, Fall F, Maxwell A, Liu JB, Forsberg F, Vlaisavljevich E, Goldberg A, Xiao TS, Kuon Yeng E C, Eisenbrey JR, Koenig G. Development of a contrast-enhanced ultrasound guided high intensity focused ultrasound system for coagulation of liver parenchyma. J Trauma Acute Care Surg. 2024 May 23. doi: 10.1097/TA.0000000000004397. PMID: 38750641 

Yang MY, Tu YF, Feng KK, Yin MD, Fang YF, Le JQ, Luo BY, Tan XR, Shao JW. A erythrocyte-platelet hybrid membrane coated biomimetic nanosystem based on ginsenosides and PFH combined with ultrasound for targeted delivery in thrombus therapy. Colloids Surf B Biointerfaces. 2023 Jul 18;229:113468. doi: 10.1016/j.colsurfb.2023.113468. PMID: 37515961  

Bautista KJB, Kim J, Xu Z, Jiang X, Dayton PA. Current Status of Sub-micron Cavitation-Enhancing Agents for Sonothrombolysis. Ultrasound Med Biol. 2023 May;49(5):1049-1057. doi: 10.1016/j.ultrasmedbio.2023.01.018. Epub 2023 Mar 1. PMID: 36868959  

Heo J, Park JH, Kim HJ, Pahk K, Pahk KJ. Sonothrombolysis with an acoustic net-assisted boiling histotripsy: A proof-of-concept study. Ultrason Sonochem. 2023 Jun;96:106435. doi: 10.1016/j.ultsonch.2023.106435. Epub 2023 May 8. PMID: 37178667  

Click here for additional references from PubMed.