Mevion Medical Systems, based in Littleton, Mass., has submitted a 510(k) premarket notification to the FDA for the MEVION S250i proton therapy system with HYPERSCAN Pencil Beam Scanning (PBS) technology.

“We focused on addressing the challenges clinicians faced with first-generation systems and engineered a novel and transformative solution,” says Joseph Jachinowski, CEO of Mevion Medical Systems.

Designed to deliver faster, sharper, and more robust pencil beam scanning fields, the HYPERSCAN Pencil Beam Scanning technology incorporates faster energy layer switching, optimized spot sizes, and the Adaptive Aperture proton collimation system. The Adaptive Aperture is the world’s first commercial PBS multileaf collimator capable of multilayer conformal field delivery. The system provides dose gradient advantages with up to three times sharper lateral penumbra, which can reduce dose uncertainty at the edge of the tumor, spare healthy tissue, and prevent unnecessary radiation to sensitive locations.

“Delivering sharp field edges has been a real challenge for PBS, especially in shallow fields,” says  Skip Rosenthal, vice president of clinical education at Mevion Medical Systems. “In intracranial procedures, where critical structures are in close proximity to tumors at shallow depths, having the sharpest lateral penumbra is essential. The sharp penumbras of the Adaptive Aperture system have substantial benefits for these patients.”

The first MEVION S250i Proton Therapy System has been installed at MedStar Georgetown University Hospital in Washington, D.C. and is currently undergoing final testing. Upon 510(k) clearance, the MedStar Georgetown University Hospital Proton Therapy Center will be the first in the world to treat patients using the HYPERSCAN technology. This will also be the first and only proton therapy system in the Washington, D.C. metropolitan area.