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 calcifications on their heart valves. This novel technology focuses beams of ultrasonic energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.
How it Works
Where the beams converge, pulsed cavitational focused ultrasound (or histotripsy) is intended to deliver mechanical energy to the calcium deposits on the valve. This is designed to increase their ability to open and improve blood flow.
Cardiawave is being studied for treatment of patients with aortic stenosis caused by calcifications on their aortic valves. The initial use is for patients with severe, symptomatic aortic stenosis patients.
Advantages
The primary option for treatment of calcification of the heart valves is 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 treatment improves both the calcification and the flexibility of the patient’s valve, and there are no issues related to the mechanical replacements or requirements for anticoagulants.
Clinical Trials
In another action Cardiawave had a proposed clinical trial for treating moderate aortic stenosis (as opposed to the existing indication for severe stenosis) but the company has decided not to pursue this indication currently.
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 heart valve calcifications is not yet approved by regulatory bodies or covered by medical insurance companies.
Notable Papers
Magnier C, Kwiecinski W, Escudero DS, Amis G, Goudot G, Mousseaux E, Messas E, Pernot M. A 3D Numerical Model of Ultrasonic Transthoracic Propagation for Cardiac Focused Ultrasound Therapy. IEEE Trans Biomed Eng. 2025 Oct 6;PP. doi: 10.1109/TBME.2025.3618103. PMID: 41052173
Messas E, Ijsselmuiden A, Trifunović-Zamaklar D, Cholley B, Puymirat E, Halim J, Karan R, van Gameren M, Terzić D, Milićević V, Tanter M, Pernot M, Goudot G. Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study. Lancet. 2023 Nov 13:S0140-6736(23)01518-0. doi: 10.1016/S0140-6736(23)01518-0. Online ahead of print. PMID: 37972628
Trifunovic-Zamaklar D, Velinović M, Kovačević-Kostić N, Messas E. Systematic brain magnetic resonance imaging and safety evaluation of non-invasive ultrasound therapy for patients with severe symptomatic aortic valve stenosis. Eur Heart J Cardiovasc Imaging. 2023 May 9:jead089. doi: 10.1093/ehjci/jead089. Online ahead of print.PMID: 37158997
Messas E, IJsselmuiden A, Goudot G, Vlieger S, Zarka S, Puymirat E, Cholley B, Spaulding C, Hagège AA, Marijon E, Tanter M, Bertrand B, Rémond MC, Penot R, Ren B, den Heijer P, Pernot M, Spaargaren R. Feasibility and Performance of Noninvasive Ultrasound Therapy in Patients With Severe Symptomatic Aortic Valve Stenosis: A First-in-Human Study. Circulation. 2021 Mar 2;143(9):968-970. doi: 10.1161/CIRCULATIONAHA.120.050672. Epub 2021 Jan 25.
Olivier Villemain, MD, Justine Robin, MS, Alain Bel, MD, Wojciech Kwiecinski, PhD, Patrick Bruneval,MD, Bastien Arnal, PhD, Mathieu Rémond, PhD, Mickael Tanter, PhD, Emmanuel Messas, MD, PhD, Mathieu Pernot, PhD. Pulsed Cavitational Ultrasound Softening : A New Noninvasive Therapeutic Approach for Calcified Bioprosthetic Valve Stenosis JACC: Basic to Translational Science Volume 2, Issue 4, August 2017, Pages 372-383.
Petrusca L, Salomir R, Milleret R, Pichot O, Rata M, Cotton F, Chapelon JY. Experimental investigation of thermal effects in HIFU-based external valvuloplasty with a non-spherical transducer, using high-resolution MR thermometry. Phys Med Biol. 2009 Sep 7;54(17):5123-38. doi: 10.1088/0031-9155/54/17/004. Epub 2009 Aug 6.
Click here for additional references from PubMed.