Mevion files for FDA clearance for S250i proton therapy system

Mevion Medical Systems said yesterday it submitted a 510(k) premarket notification to the FDA for its Mevion S250i proton therapy system with Hyperscan pencil beam scanning tech.

The Mevion S250i features improved pencil beam scanning fields and Hyperscan pencil beam scanning tech to allow for faster energy layer switching, the Littleton, Mass.-based company said.

“We focused on addressing the challenges clinicians faced with 1st generation systems and engineered a novel and transformative solution,” CEO Joseph Jachinowski said in a press release.

The system also features the company’s Adaptive Aperture multi-leaf collimator designed for multi-layer conformal field delivery, Mevion said, which it claims provides dose gradients with up to 3 times sharper lateral penumbra.

“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. 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,” clinical education VP Skip Rosenthal said in a prepared statement.

Last September, Mevion announced its latest development in proton therapy, touting improvements that could allow its Hyperscan system to treat tumors other proton therapy systems cannot.

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