Home Diseases and Conditions Septal Perforation

Septal Perforation

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Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound research for this condition is in the laboratory phase and is not yet available for patients.

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 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.

How it Works
Where the beams converge, the focused 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.

Advantages
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 – such as surgical wound healing or infection – at a lower cost. Focused ultrasound can also reach the desired target without damaging surrounding tissue, and it can be repeated, if necessary.

Clinical Trials

At the present time, there are no clinical trials recruiting patients for focused ultrasound septal perforation.

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/. 

See here for a list of laboratory research sites >

Regulatory Approval and Reimbursement

Focused ultrasound treatment for septal perforation is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Jang KW, Tu TW, Nagle ME, Lewis BK, Burks SR, Frank JA. Molecular and histological effects of MR-guided pulsed focused ultrasound to the rat heart. J Transl Med. 2017 Dec 13;15(1):252. doi: 10.1186/s12967-017-1361-y.

Zheng M, Shentu W, Chen D, Sahn DJ, Zhou X. High-intensity focused ultrasound ablation of myocardium in vivo and instantaneous biological response. Echocardiography. 2014 Oct;31(9):1146-53. doi: 10.1111/echo.12526.

Alkins R, Huang Y, Pajek D, Hynynen K. Cavitation-based third ventriculostomy using MRI-guided focused ultrasound. J Neurosurg. 2013 Dec;119(6):1520-9. doi: 10.3171/2013.8.JNS13969.

Miller RM, Kim Y, Lin KW, Cain CA, Owens GE, Xu Z. Histotripsy cardiac therapy system integrated with real-time motion correction. Ultrasound Med Biol. 2013 Dec;39(12):2362-73. doi: 10.1016/j.ultrasmedbio.2013.08.004. Epub 2013 Sep 21.

Click here for additional references from PubMed.