Monteris Medical wins early FDA approval AutoLITT System

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.