Key Points
- While EDAP’s Focal One platform already has FDA clearance to treat the prostate, recent results indicate it is also effective for rectal endometriosis.
- The FDA’s Breakthrough Devices Program allows fast-tracking of certain novel devices and expedites patient access to treatments.
EDAP TMS announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its Focal One high-intensity focused ultrasound (HIFU) platform for treating deep infiltrating rectal endometriosis.
Rectal endometriosis causes painful lesions that can seriously impact quality of life for many women. Focal One HIFU is a noninvasive, robotic ablative procedure using a high-intensity ultrasound probe to deliver tissue devitalization through use of acoustic cavitation and thermal ablation. Recent study results showed that patients experienced a significant decrease in symptoms, such as acute pelvic pain, dyspareunia, diarrhea, constipation, rectal bleeding, false urges, tenesmus, rectal spams, posterior pelvic pain, and asthenia one month after being treated with the Focal One device. Moreover, patients experienced sustained symptom relief after up to six months.
Until now, the Focal One device has been used to treat diseases of the prostate, including prostate cancer and benign prostatic hyperplasia (often called BPH). In June 2018, the FDA cleared the device for the ablation of prostatic tissue.
“Receiving Breakthrough Device designation from the FDA represents a major milestone and reinforces our commitment to expand the use of Focal One Robotic HIFU technology to treat other patient conditions beyond prostate disease,” said Ryan Rhodes, chief executive officer of EDAP TMS, in the company’s press release. “This designation reflects the FDA’s recognition that deep infiltrating endometriosis remains a significant unmet medical need in women’s health with few treatment alternatives. By expanding our proprietary robotic HIFU technology, we aim to provide women with a safe and effective treatment option that is significantly less invasive and less morbid than conventional surgical approaches.”
The Breakthrough Devices Program was established by the FDA in 2018 to allow fast-tracking of certain novel devices.
“The program offers device manufacturers an opportunity to work directly with the FDA through the premarket review stage of the approval process,” explains Jessica Foley, PhD, the Foundation’s chief scientific officer and managing director of government affairs. “The goal is to expedite patient access to devices that provide more effective treatment or diagnosis, through a more rapid assessment and review process, while preserving the FDA’s standards of approval.”
Four other focused ultrasound companies have earned Breakthrough Device designation for their products: HistoSonics for its EdisonTM histotripsy platform, Acoustiic for its ultrasound arrays, Carthera for its SonoCloud-9 device for glioblastoma, and Cordance Medical for its NeuroAccess liquid biopsy device.