Mevion Medical Systems Submits 510(K) Premarket Notification For The MEVION S250i Proton Therapy System With HYPERSCAN Technology

LITTLETON, Mass.--(BUSINESS WIRE)--Mevion Medical Systems, a worldwide leader of compact proton therapy solutions, announced today 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 today. “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.

Next Generation Intensity Modulated Proton Therapy (IMPT)

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.”

World’s First HYPERSCAN PBS Installation

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.

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 including the world’s only gantry mounted superconducting synchrocyclotron, a six degree-of-freedom treatment couch and advanced in-room IGRT imaging is all leveraged in the S250i system. This compact, fully integrated platform has years of successful clinical experience and now will deliver next generation pencil beam scanning.

“The MEVION S250i system represents the next generation of intensity modulated proton therapy (IMPT) delivered in the most advanced compact proton therapy platform,” said Jachinowski. “By incorporating HYPERSCAN technology, we are adding a highly precise, field advancing capability to a platform that is demonstrably reliable, economically sound and clinically efficient for cancer centers around the globe.”

Mevion customers have achieved the fastest per-room patient ramp-up in the history of proton therapy. High throughputs have been achieved due to the MEVION S250 Series efficient, linac-like workflow, low maintenance requirements, and industry-leading uptime. Demonstrating that compact proton therapy can be 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.

Expanding Proton Therapy Adoption

The HYPERSCAN technology is becoming available at a point in time of growing evidence and acceptance of proton therapy as a treatment modality. Proton therapy provides targeted radiation treatment for many types of cancer, significantly reducing the dose of radiation to healthy tissue by as much as a factor of three, while still maintaining high conformance to the treatment target. The National Comprehensive Cancer Network (NCCN) recently updated its clinical practice guidelines to add proton therapy as an appropriate therapy in the management of several additional critical indications including esophageal carcinomas, head and neck, hepatobiliary and non-small-cell lung carcinomas.

More information about the MEVION S250i system with HYPERSCAN Pencil Beam Scanning will be available at Mevion booth (#1135) at the 2017 Annual American Society for Radiation Oncology (ASTRO) meeting in San Diego, CA from Sunday September 24^th through September 26^th.

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.

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 beam 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™ and Adaptive Aperture™ 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.