Mevion Submits 510(k) Premarket Notification for Proton Therapy System with HYPERSCAN Technology

Mevion Medical Systems has announced the submission of its 510(k) Premarket Notification to the U.S. Food & Drug Administration (FDA) for the MEVION S250i Proton Therapy System with HYPERSCAN Pencil Beam Scanning (PBS) technology.

The MEVION S250i system is a groundbreaking change to the way pencil beam scanning proton therapy is delivered.

“We focused on addressing the challenges clinicians faced with first generation systems and engineered a novel and transformative solution,” said 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 multi-leaf collimator capable of multi-layer conformal field delivery. This system provides dose gradient advantages with up to a three times sharper lateral penumbra, which can reduce dose uncertainty at the edge of the tumor thus sparing healthy tissue and preventing unnecessary radiation to sensitive locations.

“Delivering sharp field edges has been a real challenge for PBS, especially in shallow fields. 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,” said Skip Rosenthal, VP of Clinical Education. “In addition, the enhanced speed of HYPERSCAN PBS could enable greater confidence in treating thoracic tumors. Motion management issues stemming from slow delivery times have limited the use of PBS in lung tumors. HYPERSCAN PBS can deliver a lung tumor treatment in a single breath-hold which could have a game changing impact to this indication.”

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.