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.
How it Works
Where the beams converge, pulsed cavitational focused ultrasound (or histotripsy) will deliver mechanical energy to the calcium deposits on the valve. This improves blood flow and the valves’ ability to open. This is similar to lithotripsy, which is used on kidney stones.
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.
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.
A pivotal clinical trial in Europe is organizing for aortic valve calcifications causing severe aortic stenosis.
A clinical trial in Serbia is treating patients with severe aortic stenosis.
Regulatory Approval and Reimbursement
Focused ultrasound treatment for heart valve calcifications is not yet approved by regulatory bodies or covered by medical insurance companies.
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