Monteris® Medical First-In-Humans Trial Published
PLYMOUTH, Minn.--(BUSINESS WIRE)--Apr 29, 2013--Monteris Medical announced that their First-In-Humans clinical trial with the NeuroBlate ® System for neurosurgical ablation has been published in the Journal of Neurosurgery. This study was a thermal dose-escalation trial to assess the safety and efficacy of the NeuroBlate System to treat recurrent Glioblastoma Multiforme (GBM) brain tumors. "Although not a large trial, it is significant as a foundation on which to build the clinical data needed for broad technology adoption," said Dr. Andrew Sloan, Director of the Brain Tumor & Neuro-Oncology Center, Vice Chairman of Neurosurgery and holder of the Peter D. Cristal Chair of Neurosurgical Oncology at University Hospitals-Case Medical Center and an investigator in the trial. “Furthermore, this is the first contemporary report of a trial using laser interstitial thermal therapy for gliomas, which are a particularly difficult type of brain tumor to treat and have a very poor prognosis.” Ten patients with recurrent or progressive GBM who had failed standard therapy (radiotherapy with or without chemotherapy) and were deemed to have “inoperable recurrent GBM” were enrolled in the trial. The patients were divided into three groups defined by the amount of laser energy (dose) delivered to the tumor with the NeuroBlate System. “The median survival time of 316 days seen in this cohort of patients is encouraging, as compared to the 90-150 day median survival typically observed for recurrent GBM’s,” stated Dr. Gene Barnett, Professor and Director of the Rose Ella Burkhardt Brain Tumor and Neuro-Oncology Center, Vice-Chair of Neurosurgery and Rose Ella Burkhardt Chair of Neuro-Oncology Research at Cleveland Clinic. “These patients not only have a poor prognosis, but have limited treatment options. We believe that the NeuroBlate System will be an important tool for neurosurgeons and will allow us to treat patients who might otherwise have few options.” Dr. Barnett was the Principal Investigator in the trial and is Consulting Medical Director for Monteris.
The full article is available on the Journal of Neurosurgery website www.thejns.org/action/showAllForthcomingToc
About Monteris Medical
Monteris ® Medical is a privately held medical device company dedicated to the development of innovative MRI-guided, laser-based brain treatments. Monteris ® Medical markets the NeuroBlate ® System, a neurosurgical device providing controlled ablation for difficult-to-treat brain lesions. www.monteris.com