From the April 2016 issue of HealthCare Business News magazine
In addition to opening the market for prostate treatment, Sonacare and EDAP’s focused ultrasound systems also provide new diversity in focused ultrasound imaging approach. A key benefit of the technology is that it allows for real-time treatment monitoring. These new prostate systems are ultrasound-guided, with the imaging built into their systems, making them fairly mobile and cost-effective. Each system was designed specifically for treating the prostate, yet some hardware may serve as a platform for future devices and indications. The Sonablate system was approved through the
FDA’s de novo 510(k) process, which then allowed for EDAP to utilize the 510(k) pathway.
This could potentially enable a quicker and more streamlined regulatory pathway for future focused ultrasound devices. The other focused ultrasound system in the U.S. market, developed by Israeli company Insightec, is approved for the treatment of uterine fibroids and pain from bone metastases. This ExAblate system is magnetic resonance (MR)-guided, enabling MR thermometry for treatment monitoring.
This system serves as a platform for other uses being researched, like soft tissue tumor ablation. The different types of focused ultrasound systems give providers choices on what fits best into their practice or hospital system.
Beyond ablation — opening the blood brain barrier
Recent developments demonstrate focused ultrasound’s reach far beyond that of a simple tool for ablation. This past November, focused ultrasound was used for the first time to noninvasively open the blood-brain barrier (BBB), enabling more effective delivery of chemotherapy into a patient’s malignant brain tumor. A team at Sunnybrook Health Sciences Centre infused the chemotherapy agent doxorubicin, along with gas-filled microbubbles, into the bloodstream of a patient with a brain tumor. They then applied focused ultrasound to areas in the tumor and surrounding brain, causing the micro-bubbles to vibrate, loosening the tight junctions of the cells comprising the BBB and allowing delivery of the chemotherapy to the targeted tissues.
While this recent experience is a first-inhuman achievement, numerous pre-clinical studies over the past decade have demon strated the ability of focused ultrasound to safely and temporarily open the blood brain barrier with micro-bubbles. Research has shown that this approach may not only enable drug delivery, but might also stimulate the brain’s natural immune response.
