Monteris Medical wins FDA IDE nod for another NeuroBlate brain cancer trial

Monteris Medical said today it won FDA investigational device exemption to explore the use of its NeuroBlate system in patients newly diagnosed with glioblastoma multiforme. The NeuroBlate system is designed to ablate, necrotize or coagulate soft tissue during neurosurgery procedures through laser thermotherapy, and is not intended for any specific disease or lesion type, the company said. With the investigative approval, Plymouth, Minn.-based Monteris said it expects to launch a new study of its device in the 4th quarter of this year, with enrollment slated for 5 sites in the U.S. “Glioblastoma multiforme continues to be one of the most lethal cancers, and new approaches for managing this disease are urgently needed. Preliminary data suggest that LITT may have potential in newly diagnosed GBM cases, and the FLAG study will further our understanding of its potential in improving the care and outcomes for patients. Additionally, we anticipate LITT’s minimally invasive approach may have benefits over open craniotomy for this population,” Dr. Eric Leuthardt of the Barnes-Jewish Hospital said in a press release. The 12-month study aims to examine the safety, feasibility and effectiveness of the NeuroBlate system in combination with standard of care radiation and chemotherapy for patients with newly diagnosed GBM. “Although complete tumor resection in GBM is associated with improved survival, traditional open surgery is not optimal for patients with diff...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Neurological Monteris Medical Source Type: news