The U.S. Food & Drug Administration gave premarket approval to a minimally invasive laser surgery for brain tumors that is being tested at Cleveland Clinic and University Hospitals Case Medical Center.
The AutoLITT System from Monteris Medical uses an MRI to guide the laser, allowing doctors to watch and adjust as they heat glioblastoma multiforme (GBM) tumors, reduce them to a pasty state and remove the tumor. Company officials say the device is ideal to manage these difficult-to-reach tumors and researchers think the approach could treat half of the 8,000 annual recurrent GBM tumors.
The FDA’s 510(k) clearance approves the AutoLITT system for use in neurosurgery, according to a company press release. Clinic and UH researchers planned to finish a Phase 1 study this year and start on a second study as early as the end of 2009.
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In about 1988, Dr. Frank Jolesz at Brigham and Womens Hospital put a laser fiber in the brain of a rabbit inside a GE 1.5T SIGNA, and in a series of rapid MR images showed what looked like water running out of a hose. This was the first demonstration I had ever seen of MR thermal imaging, or a demonstration of MR guided thermal surgery. Several sites reproduced this effect, and several human series with LITT have been published.
While there are several other systems (focused ultrasound, microwave and RF ablation) tested and some in commercial use, it is good to see someone move forward with a potential commercial system in this area as well.
Comment by Rob Newman — May 14, 2009 @ 2:39 pm
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