The US Food and Drug Administration (FDA) has granted 510(k) clearance for radiotherapy devices provider Qfix for its Encompass SRS immobilisation system for use in stereotactic radiosurgery (SRS).
Encompass, which is currently used for intracranial radiotherapy treatments, is cleared to achieve sub-millimetre immobilisation to precisely treat multiple lesions with a single isocentre.
Qfix CEO Dan Coppens said: "We are delighted to receive FDA clearance. The potential clinical benefits for patients are significant."
The system uses a posterior thermoplastic and anterior open view mask that is compatible with optical tracking systems.
Encompass SRS immobilisation system when combined with SRS Fibreplast system provides high-precision, sub-millimeter accuracy and immobilisation for stereotactic radiosurgery.
An optional IntegraBite can also be used to further reduce motion and provide a maximum dose to the tumour, while minimising radiation delivered to surrounding healthy tissue.
The integrated Shim system of the SRS Fibreplast system provides a 4mm range of height adjustment using discrete 0.5mm increments to optimise immobilisation.
The SRS immobilisation system is designed to optimise workflow efficiencies, increase patient throughput and improve patient outcomes.
The company is providing the Encompass SRS immobilisation system as a kVue insert for use in simulation on kVue CT and treatment on kVue couch top.
kVue couch top is a standalone device for use with non-kVue CT simulation and treatment surfaces. It is currently available in an MRI compatible standalone device for MR imaging and treatment (patents pending).