Monteris Medical Earns 510(k) Clearance for AutoLITT(TM)
KALAMAZOO, Mich., and WINNIPEG, Manitoba, May 13 /PRNewswire/ -- An MRI-guided laser surgery method, in investigational use at both The Cleveland Clinic and University Hospitals Case Medical Center, holds promise for thousands of brain tumor patients and has earned clearance from the Food and Drug Administration (FDA) for use in neurosurgery. The first applications of the technology are expected to be for the treatment of otherwise inoperable brain tumors.
The AutoLITT System uses an MRI-guided laser probe, passed through a small bur hole in the skull, to deliver laser interstitial thermal therapy ("LITT") to heat and coagulate the tumor from the inside. High-intensity laser energy is applied directly to the tumor, rather than passing through normal tissue, while the MRI measures the temperature inside the brain, showing thermal damage as it happens and facilitating precise control of the treatment. Once coagulated, the treated tumor mass is dead.
"The AutoLITT procedure delivers new-found hope for patients who have previously been given limited options in the treatment of their tumors," explains
James Duncan, president and CEO of Monteris Medical, the AutoLITT manufacturer. The system offers a potential option for patients with tumors that are too difficult or too risky to treat, tumors that don't respond to other treatments, and tumors in patients that are otherwise not good candidates for surgery or radiosurgery.
About Monteris Medical
Monteris Medical(TM) Inc. is a medical device company dedicated to developing new cancer treatment technologies that improve clinical outcomes, quality of life, and the cost and complexity of care. The company's U.S. corporate headquarters are in Kalamazoo, Michigan. R&D headquarters are in Winnipeg, Manitoba, Canada. The website iswww.monteris.com.