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 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.
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.
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.
Regulatory Approval and Reimbursement
Focused ultrasound treatment for PAD is not yet approved by regulatory bodies or covered by medical insurance companies.
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.
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Devanagondi R, Zhang X, Xu Z, Ives K, Levin A, Gurm H, Owens GE. 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.
Almekkaway MK, Shehata IA, Ebbini ES. Anatomical-based model for simulation of HIFU-induced lesions in atherosclerotic plaques. Int J Hyperthermia. 2015 Jun;31(4):433-42. doi: 10.3109/02656736.2015.1018966.
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