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. Where the beams converge, the ultrasound produces a variety of biological effects enabling PAD to be treated without surgery. Mechanical fractionation of clots or ultrasound-enhanced delivery of drugs to treat the disease are 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 in severe peripheral arterial disease. This approach showed safety and vascular improvement in a small number of patients with severe arterial disease.
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 and lower cost.
- Focused ultrasound is noninvasive, 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.
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.
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. https://www.asgct.org/global/documents/asgct19_abstracts_-final Item 93
Lee TH, Yeh JC, Tsai CH, Yang JT, Lou SL, Seak CJ, Wang CY, Wei KC, Liu HL. Improved thrombolytic effect with focused ultrasound and neuroprotective agent against acute carotid artery thrombosis in rat. Sci Rep. 2017 May 9;7(1):1638. doi: 10.1038/s41598-017-01769-2.
Papadopoulos N, Yiallouras C, Damianou C. The Enhancing Effect of Focused Ultrasound on TNK-Tissue Plasminogen Activator-Induced Thrombolysis Using an In Vitro Circulating Flow Model. J Stroke Cerebrovasc Dis. 2016 Dec;25(12):2891-2899. doi: 10.1016/j.jstrokecerebrovasdis.2016.07.052.
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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