Radiotherapy devices provider Qfix has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its the Encompass SRS immobilization system for use in stereotactic radiosurgery (SRS).
Encompass, which is currently used for intracranial radiotherapy treatments, has now cleared to approval to achieve sub-millimeter immobilization to precisely treat multiple lesions with a single isocenter.
Qfix CEO and chief technology officer 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 compatible with optical tracking systems.
Through aggregating with Encompass SRS Fibreplast system, the Encompass provides high-precision, sub-millimeter accuracy and immobilization for stereotactic radiosurgery.
The optional IntegraBite can also be used to further reduce motion, allowing to offer maximum dose to the tumor while minimizing radiation delivered to the surrounding healthy tissue.
Encompass SRS Fibreplast system’s Integrated Shim system offers a 4mm range of height adjustment using discrete 0.5mm increments to enhance immobilization.
Qfix is providing the Encompass SRS immobilization system as a kVue Insert for use in simulation on kVue CT and treatment on kVue Couch Top.
The 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).
Image: Qfix has obtained FDA approval for Encompass SRS immobilization system. Photo: courtesy of Stuart Miles / FreeDigitalPhotos.net.