Focused Ultrasound Therapy
Focused ultrasound is an early-stage, non-invasive, 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. Where the beams converge, the ultrasound produces a variety of therapeutic effects enabling calcified deposits on the valves to be treated.
This approach uses pulsed cavitational focused ultrasound, also known as histotripsy, which delivers high intensity ultrasound to the target where it alters the structure of the calcium deposits on the valve, which improves the valves ability to open and improves blood flow. This is similar to lithotripsy, which is used on kidney stones. The mechanism for histotripsy is that tiny microbubbles form and impact the target tissue resulting in fragmentation of the calcium deposits, which enables better valve opening.
The primary option for treatment of calcification of the heart valves is surgery. For certain patients, focused ultrasound could provide a non-invasive alternative to surgery with less risk of complications and lower cost.
Cardiawave is treating patients with aortic stenosis that have calcifications on their aortic valves. The initial use is for patients with severe, symptomatic aortic stenosis patients. This study is believed to be the first in human treatment.
- Focused ultrasound is a noninvasive approach, without surgical risks of infections or healing
- Focused ultrasound treatment improves both the calcification and the flexibility of the patients valve
- There are no issues related to the mechanical replacements or requirements for anticoagulants
They are beginning a clinical trial in Europe, for severe aortic stenosis patients who are not candidates for open aortic valve replacement or transcatheter aortic valve replacement.
Regulatory Approval and Reimbursement
Focused ultrasound treatment for heart valve calcifications is not yet approved by regulatory bodies or covered by medical insurance companies.
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.
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