Mevion Medical Systems, Inc. (Littleton, MA, USA), a radiation therapy company focused advancing the treatment of cancer, has received US Food and Drug Administration (FDA) 510(k) clearance for its MevionS250 proton therapy system.
The Mevion S250 is a first-of-its-kind proton therapy system that provides the same precise, noninvasive treatment advantages and capabilities of complex, large, and expensive proton therapy systems but with higher patient throughput, a significantly reduced footprint, improved effectiveness, and lower implementation and operational costs. The Mevion S250 delivers exact and intense proton beams that physicians can use to treat tumors and lesions or any other condition where radiotherapy is indicated.
The wide adoption of proton therapy has been greatly limited by the immense cost, large footprint, and technical complexity of traditional proton therapy systems. Fueled by a patented triniobium core, the 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 (MO, USA).
Mevion will be delivering and installing more than a dozen Mevion S250 proton therapy systems worldwide within the next two years. Earlier in 2012, the Mevion S250 received CE certification, which gives Mevion the ability to market, import, and install proton therapy systems in the European Union (EU) and other regions where the CE Marking is recognized.
Mevion Medical Systems, Inc. is a radiation therapy company dedicated to advancing the treatment of cancer. Mevion’s flagship product, the Mevion S250 proton therapy system, is designed to preserve all of the treatment advantages of traditional proton therapy systems while removing the hurdles of size, cost, and complexity.
Source:
medimaging.net
