Megan Bailey, Oncology Roundtable
The FDA has recently approved the MEVION S250 proton therapy system, which aims to reduce costs and make proton beam therapy more widely available.
View the post below to see an analysis of the FDA's decision from our colleagues in Technology Insights.
After eight years, the proton therapy system becomes available in the U.S.
On June 11, Mevion Medical Systems (formerly Still River Systems) announced the MEVION S250 system's FDA 510(k) clearance. A milestone eight years in the making, the proton therapy system will now be approved for use in the U.S.
The news comes just three months after the company's CE certification, which had granted the S250 access to the European Union market. This clearance will allow providers to initiate treatment upon installation of the system, with the first S250 nearing completion at the Kling Center for Proton Therapy at Washington University in St. Louis, Missouri. Over the next two years, Mevion plans to establish the system in over a dozen locations internationally, with plans for several U.S. sites in locations such as New Jersey, Oklahoma, Florida, and California.
Proton beam therapy considered the superior treatment for several indicators
Proton beam therapy is considered to offer more precise radiation delivery to the target area, with minimal exposure to surrounding tissue. Although the clinical benefits of protons compared to traditional photon based radiation therapy systems have been widely debated, protons are often considered the superior treatment for certain indications, such as pediatric oncology patients. Ongoing clinical investigation of protons, a hot topic in the oncology community, will continue to weigh heavily upon the rate of expansion of these treatments.
Small-scale technology with a large-scale interest level
Although it has been pending FDA clearance for a number of years, this small-scale proton technology has generated significant interest from many institutions, including some of the most progressive cancer centers in the world.
Until now, the major barriers to widespread adoption have been:
- Large capital costs
- Technical complexity
- Extensive training demanded by existing proton therapy systems
The MEVION S250, however, aims to substantially reduce the upfront and recurring costs associated with offering proton therapy. While still anticipated to be many multiples of the costs required for offering conventional X-ray radiation therapy, small-scale systems have driven an evolution in the types of hospitals considering this modality.
For more information on proton therapy, view Technology Insights' blog post, "Proton therapy update."