CE Mark for MEVION S250i Proton Therapy System
CE Marking permits clinical use of the system within the European Union and any country that recognizes the CE Mark.
LITTLETON, Mass., November 13, 2017 – Mevion Medical Systems announced today that the MEVION S250i Proton Therapy System® has achieved CE Marking clearance. The MEVION S250i system includes HYPERSCAN™ technology, the next generation of pencil beam scanning (PBS) for faster, sharper, and more robust proton treatments.
“This milestone is part of Mevion’s global expansion of cutting-edge compact proton therapy systems in Europe,” said Perjan Pleunis, Field VP of Business Development (EMEA). “Mevion has led the way in establishing compact proton therapy as the most technologically advanced and financially viable choice in proton therapy.” European CE Marking is the first regulatory clearance for the MEVION S250i system. Mevion also submitted for US FDA 510(k) clearance in September.
First European Installation
The first European MEVION S250i proton therapy system installation will be completed in 2018 at the Zuid-Oost Nederland Protonen Therapie Centrum (ZON PTC) at the Maastro Clinic in Maastricht, the Netherlands.
The MEVION S250i system will be the first of its kind in Europe. Designed to deliver faster, sharper, and more robust treatments, the HYPERSCAN PBS technology incorporates the fastest energy layer switching, optimized spot sizes, and the Adaptive Aperture™ proton multi-leaf collimator system. This capability provides dose gradient advantages with up to a three times sharper lateral penumbra reducing dose uncertainty at the edge of the tumor thus sparing healthy tissue and preventing unnecessary radiation to sensitive locations. This improved precision in delivery is combined with hyper-fast beam delivery reducing the sensitivity to motion that current PBS technologies face when treating moving lesions such as those in the thoracic cavity.
Built on Leading Compact Proton Therapy Technology
The MEVION S250i system is based on Mevion’s high efficiency, low financial risk S250 Series platform. The core technology of the S250 Series includes the world’s only gantry mounted superconducting synchrocyclotron, a six degree-of-freedom treatment couch and advanced in-room IGRT imaging, all leveraged in the S250i system. This compact, fully integrated platform has years of successful clinical experience, proven financial viability and now delivers next generation pencil beam scanning.
The MEVION S250i lowers the cost per patient by reducing capital costs, reducing operating costs, and increasing treatment throughput. Mevion customers have achieved the fastest per-room patient ramp-up in the history of proton therapy. High throughput is achieved via linac-like workflow, low maintenance requirements, and industry-leading uptime. Demonstrating that compact proton therapy is a viable option for any size cancer center is core to Mevion’s mission of making proton therapy accessible to as many patients as possible.
About Mevion Medical Systems®
Mevion Medical Systems, Inc. is a leading provider of proton therapy systems for use in radiation treatment for cancer patients. Mevion is based in Littleton, Massachusetts, with a presence in the Europe, Japan and China. For more information, please visit www.mevion.com.
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About the MEVION S250™ Series
The MEVION S250 Series is elegantly designed to deliver high-powered, efficient proton therapy treatments. Built upon the world’s only gantry-mounted proton accelerator and benefiting from Mevion’s patented Direct Dose™ beam delivery technology, the MEVION S250 Series delivers on the therapeutic promise of proton therapy while enhancing beam quality, stability and uptime. The result is a high-quality treatment with reduced system complexity, higher reliability and throughput, and lower capital and operating costs—making the MEVION S250 Series a compelling, financially viable solution for all cancer centers.
The MEVION S250 Series includes:
- MEVION S250 Proton Therapy System®, offering highly stable, next-generation volumetric delivery capabilities
- MEVION S250i Proton Therapy System™ with HYPERSCAN™ technology, overcoming pencil beam scanning uncertainties by delivering robust IMPT treatment at hyper-speed
- MEVION S250mx™ options, making proton therapy fully scalable, with two, three and four room designs that are inherently redundant and support 100% facility uptime
The MEVION S250i Proton Therapy System is 510(k) pending and has not been cleared by the USFDA for clinical use.