Mevion Proton Therapy System Approved in U.S., Cleared for Firing Up at Initial Hospitals

Mevion Proton Therapy System Approved in U.S., Cleared for Firing Up at Initial Hospitals

LITTLETON, MA., June 11, 2012 /PRNewswire/–Mevion Medical Systems, Inc., a radiation therapy company dedicated to advancing the treatment of cancer, announced today that it has received FDA 510(k) clearance for its MEVION S250 Proton Therapy System. The MEVION S250 is a first-of-its-kind proton therapy system that provides the same precise, non-invasive treatment advantages and capabilities of complex, large, and costly proton therapy systems but with higher patient throughput, a significantly reduced footprint, improved reliability, and lower implementation and operational costs. The MEVION S250 delivers precise and intense proton beams that physicians can use to treat tumors and lesions or any other condition where radiotherapy is indicated.

The broad adoption of proton therapy has been greatly limited by the enormous cost, large footprint, and technical complexity of traditional proton therapy systems. Powered by a patented TriNiobium Core™, the MEVION S250 proton therapy system redefines the economics, availability, and the future direction of proton therapy, by bringing the management and operation of proton therapy to levels similar to modern X-ray radiation therapy devices. “Completing this very important milestone is a testament to the maturity of the Mevion organization and its ability to manufacture, install and support a safe and effective product,” said Joseph Jachinowski, Chief Executive Officer of Mevion Medical Systems. “We are pleased to receive this clearance from the FDA and now look forward to providing our customers and their patients access to this revolutionary device.”

This clearance enables users of the MEVION S250 to immediately treat patients upon completion of their system installation. The first installation of the MEVION S250 will soon be completed at the Kling Center for Proton Therapy at Barnes Jewish Hospital at Washington University in St. Louis, Missouri.

Mevion will be delivering and installing more than a dozen MEVION S250 proton therapy systems worldwide within the next two years, making it one of the leading providers of proton therapy systems. MEVION S250 installations are also underway at Robert Wood Johnson University Hospital in New Jersey and Oklahoma University in Oklahoma. Additional sites in Florida and California will follow these installations.

Earlier this year, the MEVION S250 received CE certification, which gives Mevion the ability to market, sell, import, and install proton therapy systems in the European Union and other regions where the CE Marking is recognized.

About Mevion Medical Systems

Mevion Medical Systems, Inc. is a radiation therapy company dedicated to advancing the treatment of cancer. As the pioneering developer of proton therapy systems, Mevion provides innovative, safe, and effective solutions by transforming advances in medical technology and science into practical clinical reality.

Mevion’s flagship product, the MEVION S250 Proton Therapy System, is designed to preserve all of the treatment benefits of traditional proton therapy systems while removing the obstacles of size, cost, and complexity. Realizing this vision, Mevion has forever changed the economics and accessibility of proton therapy worldwide.

Founded in 2004, Mevion is a privately held company headquartered in the Boston metropolitan area with international offices in the United Kingdom and Japan.

Introducing the MEVION S250

High Energy Cancer Care™

The confluence of elegance, precision, safety, and efficiency is defining the future of proton therapy. Mevion Medical Systems introduces the MEVION S250 Proton Therapy System.

Designed to preserve all of the treatment benefits of conventional proton treatment systems, the MEVION S250 removes the obstacles of size, cost and complexity that have limited adoption of proton therapy. Precise, safe, efficient, and practical – the MEVION S250™ is a truly elegant solution that is making proton therapy readily accessible to the pediatric and adult cancer patients who can now benefit from the power of High Energy Cancer Care.

The MEVION S250 Proton Therapy System is USFDA 510(k) cleared and complies with MDD/CE requirements.

Mevion Medical out of Littleton, MA received the European CE Mark for its MEVION S250 Proton Therapy System. Proton therapy’s advantage over traditional radiation is that it allows for precise targeting of tumors so that energy is deposited almost exclusively at the target without damaging tissue on the way to and away from the treatment area.

The real limiting issues with proton therapy is the cost of the systems and their large size because they are powered by synchrocyclotrons. TriNiobium Core MEVION S250 Proton Therapy Cleared in EuropeBy managing to build a compact accelerator (6 ft (1.8 m) in diameter) that can deliver protons at 250 MeV to a depth of up to 32 cm, the company believes it can bring down the cost of this technology and make it affordable to more hospitals.

Proton beam radiotherapy can accurately deliver targeted radiation doses with complete proton energy absorption at predictable tissue depth, thus allowing precise radiation delivery adjacent to critical structures and lower radiation doses to healthy structures. The availability of proton therapy has remained very limited however, due to the enormous cost, large footprint, and technical complexity of traditional proton therapy systems.

CE Marking of the MEVION S250 gives hospitals and cancer treatment centers throughout the European Union, and other regions where CE Marking is recognized, the ability to order, install, and treat patients with this revolutionary medical device. Powered by a TriNiobium Core™, the MEVION S250 significantly reduces the cost, size and complexity of proton therapy systems to levels similar to modern X-ray radiation therapy devices, and brings accessibility, affordability and practicality to proton therapy.

Mevion is concurrently installing three MEVION S250 Proton Therapy Systems in the United States. The first site at the Siteman Cancer Center in Barnes Jewish Hospital, at Washington University in St. Louis Missouri accepted delivery of its superconducting synchrocyclotron in October of 2011 and is now producing a powerful 250 MeV energy beam. The second and third installations at Robert Wood Johnson University Hospital in New Brunswick, NJ and Oklahoma University, OK are underway and scheduled to be completed later this year.

Source : http://www.mevion.com/news/67-fda-approved

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