Cranial Indication-Specific Radiosurgery Software Gets FDA Nod
After the positive reception of its Elements Multiple Brain Mets SRS software, Brainlab felt that introducing Elements Cranial SRS and Spine SRS was the next natural step. And therefore, added two further indications to their portfolio, expanding our radiosurgery focus to encompass primary tumors.
The medical technology company has now announced the FDA clearance for for Elements Spine SRS and Elements Cranial SRS, two software applications that aid in the patient-tailored planning of radiosurgery treatments for indications of the spine and brain.
With FDA clearance of these software modules, the Brainlab Elements portfolio of applications that facilitate quick planning, spare organs at risk, and create highly conformal radiation doses in the brain and spine is complete and ready for clinical use in the United States.
“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,” commented Stefan Vilsmeier, President and CEO, Brainlab. “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.
”Elements Spine SRS and Elements Cranial SRS gained CE Mark approval in May.
Elements Spine SRS accounts for variations in the curvature of the spine and ensures that high doses of radiation are delivered to the tumor and not the spinal cord itself, Brainlab said. Another application, Elements Cranial SRS, allows physicians to create a radiosurgery plan in less than 15 minutes, and it supports indications such as 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,” commented Manuel Todorovic, Head of Clinical Physics at University Hospital Hamburg-Eppendorf. “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.”
