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.<\/p>\n\n\n\n
How it Works<\/strong> Cardiawave<\/strong><\/a> 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.<\/p>\n\n\n\n Advantages<\/strong> For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications \u2013 such as surgical wound healing or infection \u2013 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.<\/p>\n\n\n\n In another action\u00a0Cardiawave\u00a0had a proposed\u00a0clinical trial<\/strong><\/a>\u00a0for treating moderate aortic stenosis (as opposed to the existing\u00a0indication\u00a0for severe stenosis)\u00a0but\u00a0the company has decided not to pursue this\u00a0indication\u00a0currently.\u00a0<\/p>\n\n\n\n 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<\/strong><\/a>, it will take you to the latest information available from https:\/\/www.clinicaltrials.gov\/<\/strong><\/a>. <\/p>\n\n\n\n Focused ultrasound treatment for heart valve calcifications is not yet approved by regulatory bodies or covered by medical insurance companies.<\/p>\n\n\n\n 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<\/strong><\/a>. IEEE Trans Biomed Eng. 2025 Oct 6;PP. doi: 10.1109\/TBME.2025.3618103. PMID: 41052173 <\/p>\n\n\n\n Messas E, Ijsselmuiden A, Trifunovi\u0107-Zamaklar D, Cholley B, Puymirat E, Halim J, Karan R, van Gameren M, Terzi\u0107 D, Mili\u0107evi\u0107 V, Tanter M, Pernot M, Goudot G. Treatment of severe symptomatic\u202faortic\u202fvalve\u202fstenosis\u202fusing non-invasive ultrasound therapy: a cohort study.<\/strong><\/a> Lancet. 2023 Nov 13:S0140-6736(23)01518-0. doi: 10.1016\/S0140-6736(23)01518-0. Online ahead of print. PMID:\u202f37972628 <\/p>\n\n\n\n Trifunovic-Zamaklar D, Velinovi\u0107 M, Kova\u010devi\u0107-Kosti\u0107 N, Messas E. Systematic\u202fbrain\u202fmagnetic\u202fresonance\u202fimaging\u202fand\u202fsafety\u202fevaluation\u202fof\u202fnon-invasive ultrasound therapy for patients with severe symptomatic aortic valve stenosis.<\/strong><\/a> Eur Heart J Cardiovasc Imaging. 2023 May 9:jead089. doi: 10.1093\/ehjci\/jead089. Online ahead of print.PMID:\u202f37158997\u202f <\/p>\n\n\n\n Messas E, IJsselmuiden A, Goudot G, Vlieger S, Zarka S, Puymirat E, Cholley B, Spaulding C, Hag\u00e8ge AA, Marijon E, Tanter M, Bertrand B, R\u00e9mond 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. <\/a>Circulation. 2021 Mar 2;143(9):968-970. doi: 10.1161\/CIRCULATIONAHA.120.050672. Epub 2021 Jan 25.<\/p>\n\n\n\n Olivier Villemain, MD, Justine Robin, MS, Alain Bel, MD, Wojciech Kwiecinski, PhD, Patrick Bruneval,MD, Bastien Arnal, PhD, Mathieu R\u00e9mond, 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<\/a> JACC: Basic to Translational Science Volume 2, Issue 4, August 2017, Pages 372-383.<\/p>\n\n\n\n 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. <\/a>Phys Med Biol. 2009 Sep 7;54(17):5123-38. doi: 10.1088\/0031-9155\/54\/17\/004. Epub 2009 Aug 6.
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.<\/p>\n\n\n\n
The primary option for treatment of calcification of the heart valves is surgery.<\/p>\n\n\n\nClinical Trials <\/h2>\n\n\n\n
Regulatory Approval and Reimbursement<\/h2>\n\n\n\n
Notable Papers<\/h2>\n\n\n\n
Click here<\/a> for additional references from PubMed.<\/strong><\/p>\n","protected":false},"template":"","meta":{"_acf_changed":false,"_searchwp_excluded":"","_editorskit_title_hidden":false,"_editorskit_reading_time":2,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","episode_type":"","audio_file":"","podmotor_file_id":"","podmotor_episode_id":"","cover_image":"","cover_image_id":"","duration":"","filesize":"","filesize_raw":"","date_recorded":"","explicit":"","block":"","itunes_episode_number":"","itunes_title":"","itunes_season_number":"","itunes_episode_type":"","_vp_format_video_url":"","_vp_image_focal_point":[],"footnotes":""},"sw_disease_condition_cat":[5],"sw_disease_condition_stage":[20],"class_list":["post-2807","sw_disease_condition","type-sw_disease_condition","status-publish","hentry","sw_disease_condition_cat-cardiovascular"],"acf":[],"yoast_head":"\n