The FDA has given clearance to Varian's Halcyon radiotherapy system.
"We are proud that Halcyon has now received both 510(k) clearance and CE mark," Kolleen Kennedy, president of Varian's Oncology Systems business, said in a statement. "With its human-centered and user-friendly design, Halcyon is engineered to revolutionize clinical workflow. These two clearances are very important milestones in the availability of this new system and advancing cost-effective cancer care worldwide."
The image-guided volumetric intensity modulated radiotherapy (IMRT) system is more comfortable for patients and easier to use for health care providers, according to the company.
Workflow is streamlined. “The system only requires nine steps from the start to the end of treatment compared to up to more than 30 steps with older technologies,” noted the company.
It handles a wide range of cancer treatments, including advanced ones for prostate, breast, and head and neck disease.
The Halcyon has touchscreens on both sides of the machine, easing patient set-up.
It is also as much as two-times quieter than other systems, has a low couch height for easy access, and soft indirect ambient lighting in the gantry opening.
There is also a couch-mounted camera that permits therapist to monitor a patient during treatment, and noise-cancelling to make conversation between them easier.
Now that it has FDA clearance, Varian can sell the system in the U.S., but it requires Eclipse 15.1.1 treatment planning software, which is still awaiting its own 510(k) approval.
Varian
unveiled the Halcyon at the ESTRO 36 conference in Vienna, Austria, in late May.
“Everyone knows there’s a shift in health care economics in the U.S., but in other countries everyone is focused on efficiency,” Mu Young Lee, director of new product solutions at Varian, told HCB News at the time. “Whether you’re in China or France or America, we have an aging population everywhere, so the need for efficiency is important worldwide.”
Part of the change is the increase in elderly patients, which is outstripping the supply of clinicians available to treat them. The simplification pf treatment into just 9 steps should help ease the problem by speeding up workflow.
In addition, the first three steps are guided by the user interface and the system can do sharp volumetric imaging in as little as 15 seconds.
In order to support the gantry rotation speed and simultaneously deliver the treatment dose precisely to the targeted area, the Halcyon is designed with a patented dual–layer multi-leaf collimator that moves twice as fast as standard MLCs.
“Radiotherapy is very personalized medicine. When you get an advanced radiotherapy treatment, the distribution of radiation you get in your body is tailored for you,” said Lee. “The MLC is one of the critical pieces of equipment that shapes the beam that enters the patient.”
The system also has a larger, 100 centimeter gantry opening, which both accommodates larger individuals and makes all patients feel less claustrophobic.
“If we want to make a world without fear of cancer, it’s not just meeting the needs of the people who buy the system, but also meeting the needs of the people who will be treated by the machine,” said Lee.
