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 the need for septal perforation. 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 precise ablation (thermal or mechanical destruction of tissue) enabling the septum to be perforated without surgery.
Pilot clinical research has demonstrated the potential of focused ultrasound to accurately and repeatedly create focal perforations in atrial tissue without direct contact. Aside from its thermal ablative effects, focused ultrasound is also capable of precise mechanical tissue destruction through a process known as histotripsy. A preclinical study has already demonstrated the ability of histotripsy to noninvasively create an atrial septal defect in a canine model.
The primary options for treatment of those who need septal perforation include minimally 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.
At the present time, there are no clinical trials recruiting patients for focused ultrasound septal perforation.
Regulatory Approval and Reimbursement
Focused ultrasound treatment for septal perforation is not yet approved by regulatory bodies or covered by medical insurance companies.
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