Insightec said today it won FDA approval to launch a safety and feasibility trial of its Exablate Neuro, testing its ability to disrupt the blood brain barrier in patients with glioblastoma.
The Exablate Neuro device, which won FDA approval last July for treating essential tremor, uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull.
In the trial, a research team will inject commonly used a sonographic microbubble solution into the bloodstream of a patient with a malignant brain tumor, after which ultrasound will be used to oscillate the microbubbles to cause temporary disruption of the blood brain barrier.
“Clinical research is critical for pushing the boundaries of MR-guided focused ultrasound technology. Insightec continues to collaborate with leading researchers to trial new clinical applications that may have significant impact where it matters most – patient lives,” CEO & chair Dr. Maurice Ferré said in a press release.
The study is set to enroll up to 15 subjects with suspected glioblastoma who are scheduled to undergo a tumor resection, with Dr. Graeme Woodworth of the University of Maryland School of Medicine acting as principal investigator.
Last month, Insightec said it won FDA approval for a pivotal trial of its Exablate Neuro device in treating refractory Parkinson’s disease.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.