IDE granted for clinical research of MRI-guided focused ultrasound
The FDA has cleared a focused-ultrasound developer to compare the safety and efficacy of acoustic energy for treating prostate cancer against the more conservative approach of active surveillance.
Insightec, which has offices in Haifa and Miami, says it received the investigational device exemption for its Exablate Prostate system, which works with MRI guidance to ablate precisely targeted tissue.
The study’s principal investigator, Behfar Ehdaie, MD, MS, a urologic surgeon at Memorial Sloan Kettering Cancer Center, says the technology may have an “impact on the standard of care for prostate cancer treatment.”
Insightec says the new trial will build on a previous Memorial Sloan Kettering study in which Exablate Prostate reported “minimal damage to adjacent structures and low rates of impact on potency and continence.”
FDA granted the system 510(k) clearance last November and, earlier this year, physicians used it to treat its first American patient outside a research setting.
“Results from the new study will define the role of focal therapy to delay and avoid radical therapy for men with prostate cancer and support expanded clinical adoption of the technology and increased access for patients through insurance reimbursement,” Insightec says.
Full announcement here.
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Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.