US FDA clears Brainlab’s Elements Spine indication-specific radiosurgery software

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Brainlab Elements Spine
Brainlab’s Elements Spine programme

Brainlab has received US Food and Drug Administration (FDA) clearance for the Elements Spine stereotactic radiosurgery software programme. This software is designed to aid in the patient-tailored planning of radiosurgery treatments for indications of the spine.

Elements Cranial SRS has also been approved by the FDA.

Historically, radiosurgery has been used with caution for spine tumours due to the risk of causing damage to the delicate spinal cord. Brainlab Elements Spine SRS is intended to address this issue and other challenges facing spinal radiosurgery treatments, such as accounting for variations in the curvature of the spine and ensuring that high doses of radiation are delivered to the tumour and not the spinal cord itself. Contouring is streamlined and incorporates guidelines set by the International Spine Consortium.

After gaining CE approval in May 2017, Elements Spine SRS and Cranial SRS were introduced into clinical use worldwide. The first patients were treated with Spine SRS at Instituto Privado de Radioterapia Oncologica SA in Cordoba, Argentina and with Spine SRS and Cranial SRS at University Hospital Hamburg-Eppendorf in Germany.

“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.”

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