FDA OKs Accuray’s VitalHold Breast Cancer Treatment

Accuray has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its VitalHold breast package on the Radixact system. It will also be available in the EU market.
 
VitalHold helps with deep inspiration breath hold (DIBH) treatments using Radixact’s TomoDirect fixed-beam angle delivery mode, as well as an integrated and automated surface-guided radiation therapy (SGRT) solution, fraturing C-RAD’s Catalyst+ HD system. The new functionality allows Radixact to be a tool set to treat breast cancer.
 
DIBH treatments are used to minimize radiation dose to organs at risk and reduce associated complications later in the patient’s life. The patient takes a deep breath to move the heart away from the chest wall and targeted tumor. Then, the SGRT tracking system continuously monitors breathing and position with cameras to confirm appropriate positioning for radiation delivery.
 
SGRT was engineered to help effectively position patients and monitor positioning accuracy throughout radiation treatment.
 
“Our goal in introducing VitalHold for the Radixact System is to provide clinicians with additional choice and flexibility when treating the full spectrum of breast cancer cases they see daily in their practice. Now, Accuray can offer our customers the widest range of radiation treatment delivery techniques in one device, the Radixact System. This industry-leading approach demonstrates how our relentless focus on innovation has enabled Accuray to make an already great system even better, providing clinicians with tools that help ensure precise, truly personalized treatments are achievable for more patients,” Suzanne Winter, president and CEO of Accuray told the press.
 
The CT-based Radixact system enables treatment of breast cases in as little as two minutes, according to the company. TomoHelical mode continuously delivers radiation beams from 360 degrees around the patient, which can be useful in treating cancer in the breast and surrounding nodes.
 
This approach is also beneficial for patients who can’t hold their breath, which is critical for DIBH treatments. TomoDirect mode helps deliver radiation from specific, fixed angles. According to the company. Radixact radiation therapy might be an option to treat breast cancer at almost every stage and can be used after surgery, chemo, and other medications.
 
“C-RAD is incredibly proud of our collaboration with Accuray. Together, we have created a seamless integration between our systems to ensure the highest level of accuracy and efficiency for the treatment of breast cancer,” said Cecilia de Leeuw, CEO and president of C-RAD AB. “VitalHold is a powerful application of C-RAD’s proven SGRT technology—and one that’s sure to touch the lives of countless breast cancer patients.”