Orfit Industries Receives 510(k) FDA Clearance for the Aerial® Proton Couch Top System


By prototyping, testing, analyzing and close cooperation with physicists and therapists, we created a couch top that is in line with the highest technical standards, without being too complex. The combination of these factors will help in assuring the best possible clinical outcome for patients.

Orfit today announced it has received FDA 510(k) clearance for its Aerial® Couch Top for Proton Therapy.

Aerial® is an entirely new couch top that optimizes the positioning and immobilization of cancer patients during proton therapy treatment. A homogeneous treatment area is provided by eliminating all rails or other obstructions underneath the couch top. The smooth shape transitions, minimal sharp corners in the treatment area and thin design characterize the couch top. All of this while supporting a patient load up to 518 lbs. (235 kg).

To immobilize patient’s with a brain tumor or a tumor in the head and neck region, Orfit HP PRO masks help to attain the high level of reproducibility and precision that proton therapy demands. The 3-points single layer HP PRO mask allows for a planning target volume margin of 1 mm which decreases the risk of damage to healthy tissue.

“By prototyping, testing, analyzing and close cooperation with physicists and therapists, we created a couch top that is in line with the highest technical standards, without being too complex. The combination of these factors will help in assuring the best possible clinical outcome for patients”, says Emilie Cuypers, Product Manager Radiation Oncology.

Orfit Industries is proud to bring a couch top on the market that perfectly pairs with advanced proton therapy delivery techniques.

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