Brainlab said today it won FDA clearance for its Elements Spine SRS and Elements Cranial SRS radiosurgery surgical planning software applications.
The Munich, Germany-based company said that the Elements Cranial SRS is designed to allow physicians to create radiosurgery plans in less than 15 minutes, supporting plans for numerous cranial indications including arteriovenous malformations, pituitary adenoma, vestibular schwannoma, glioma, meningioma and large brain metastases.
“We are highly impressed with the dosimetric results and the speed of plan optimization. We ran a few plan comparisons between our other planning software and Elements Cranial SRS. The Brainlab software either produced plans of higher quality or plans of comparable quality in significantly shorter time,” Manuel Todorovic of the University Hospital Hamburg-Eppendorf said in a prepared statement.
The newly cleared Elements Spine SRS is designed to address issues and challenges with spinal radiology treatments, including the curvature of the spine and ensuring delivery of radiation doses to the tumor and not the spine itself.
Both software suites gained CE Mark approval in the European Union in May, the company said.
“It became clear to us many years ago that radiosurgery plans must become more tailored to both the indication and the specific patient being treated. With the positive reception of our Elements Multiple Brain Mets SRS software, which has already been used to create plans for hundreds of patients around the globe, Elements Cranial SRS and Spine SRS were a natural progression toward that goal,” prez & CEO Stefan Vilsmeier said in a press release.