MAY 18, 2009--Monteris Medical Inc. (Kalamazoo, MI) has received 501(k) clearance from the US Food and Drug Administration (FDA) for use of its AutoLITT System in neurosurgery. The AutoLITT MRI-guidedlaser surgery method is in investigational use at both The Cleveland Clinic and University Hospitals Case Medical Center. The first applications of the technology are expected to be for the treatment of otherwise inoperable brain tumors.
The 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. The probe delivers high-intensity laser energy 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," said James Duncan, president and CEO of Monteris Medical. 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.
Monteris is a medical device company focused on 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.