Mevion Receives 510(k) Clearance for HYPERSCAN Pencil Beam Scanning

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Mevion Medical Systems has received FDA 510(k) clearance for the S250i Proton Therapy System including HYPERSCAN pencil beam scanning (PBS) technology. HYPERSCAN PBS introduces novel energy layer switching and automated collimation systems. These advantages enable the S250i system to deliver faster, sharper and more robust PBS proton radiation treatments.

“The S250i system represents the next generation of intensity modulated proton therapy (IMPT) delivered in the most compact proton therapy platform,” said Joseph Jachinowski, CEO of Mevion Medical Systems. “We are proud that the MEVION S250i system now has received both FDA clearance and CE mark. This is a very important milestone in our efforts to make precision proton therapy available to more patients in the fight against cancer.”

The MEVION S250i system is a compact proton therapy system capable of delivering conformal radiation therapy treatments using HYPERSCAN pencil beam scanning technology. The design of HYPERSCAN PBS technology overcomes clinical challenges that were previously faced by first generation PBS systems.

Pencil beam scanning systems shape the delivered radiation dose by “painting” tumors spot-by-spot and layer-by-layer with sub-atomic particles. Prior to HYPERSCAN PBS, scanning proton systems struggled with delivery speed. Long delivery times can undermine the high precision of the treatment due to the target tumor shifting under normal organ motion such as breathing.

HYPERSCAN PBS uses a compact beam delivery path reducing delivery times to less than 5 seconds for some fields. This “hyper-fast” treatment delivery reduces treatment errors due to the sensitivity to motion that current PBS technologies face when treating tumors affected by organ motion.

In addition, HYPERSCAN PBS utilizes, the Adaptive Aperture proton multi-leaf collimator (pMLC). This technology uses a robotically controlled collimation system, capable of trimming the edges of the beam at every layer of delivery. This capability delivers up to a three times sharper drop off in radiation at the delivery field edge. This improves sparing of healthy tissue and limits unnecessary radiation to sensitive locations.

MedStar Georgetown University Hospital in Washington, D.C. will be the first hospital in the world to offer this latest generation of HYPERSCAN PBS once final onsite testing is completed.

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