Los sistemas médicos de Varian consiguen la AUTORIZACIÓN del FDA para el sistema de la terapia del protón

por Brendon Nafziger, DOTmed News Associate Editor | January 12, 2011
Varian Medical Systems said Monday it received U.S. Food and Drug Administration clearance for its proton therapy system, as it aims to compete with rivals such as Belgian developer Iba Particle Therapy in this high-tech market.

"With this clearance, we have reached a significant milestone in the development of the Varian Particle Therapy (VPT) business and technology," Lester Boeh, vice president of emerging businesses for Varian Medical Systems, said in prepared remarks.

The Palo Alto, Calif.-based company said its product is the first working system to deliver what it calls intensity modulated proton therapy, using pencil-beam scanning technology.

Varian said the system, to be marketed under the ProBeam brand, is already tapped to supply the Scripps Proton Therapy Center in San Diego, currently under construction and expected to be finished in 2013.

The company told Patch it initially considered undertaking separate clearances for each system sold to treatment centers, but then decided on a general clearance application. However, some FDA oversight will likely be needed for new facilities, Patch said.

Proton therapy uses precisely targeted beams of protons, rather than X-rays, to blast cancers. It's able to deposit the protons at specific depths, thereby sparing more healthy tissue, the company said.

But it's a hugely expensive system, with proton-firing cyclotrons needing to be housed in massive concrete rooms. Varian's system runs about $80 million, for the technology and software, and up to $150 million for the full installation, according to a report in Patch.

The technology for proton therapy is over a half-century old, but it was first deployed to treat patients at Loma Linda University Medical Center about two decades ago.

Varian first got involved in protons in 2007, when it acquired German proton therapy maker Accel Instruments for about $30 million.