Accuray (Nasdaq:ARAY) announced that the FDA granted 510(k) clearance to its VitalHold breast package on the Radixact system.
The company also says it expects the treatment option to become available in Europe.
VitalHold facilitates deep inspiration breath hold (DIBH) treatments. It uses the Radixact System’s fixed beam angle delivery mode (TomoDirect) and fully integrated, automated surface-guided radiation therapy (SGRT). This features the Catalyst+ HD system from C-RAD.
DIBH treatments help to minimize radiation doses to organs at risk, reducing associated complications later in life. During treatment, a patient takes a deep breath, moving the heart away from the chest wall and the targeted tumor. SGRT tracking continuously monitors the breathing and positions with cameras to confirm the position is appropriate for radiation delivery. This method allows care teams to effectively position the patient and confidently monitor their accuracy.
Adding the new functionality to Radixact enables a comprehensive toolset for treating breast cancer, Accuray said in a news release.
“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,” said Accuray President and CEO Suzanne Winter. “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.”
More about the Accuray Radixact system
Radixact, a CT linac-based system, offers multiple radiation delivery options to tailor patients’ treatment to their specific needs. It enables clinicians to treat breast cases in as little as two minutes.
The system’s TomoHelical mode allows it to continuously deliver radiation beams from 360 degrees around the patient. This enables the treatment of complex cases, such as breast cancer and cancer in surrounding lymph nodes. It also offers an option to patients unable to hold their breath for DIBH treatments.
Radixact enables precise radiation delivery to any tumor bed during every treatment while minimizing doses to nearby healthy organs and tissues. It allows for radiation therapy as a treatment option for breast cancer at almost every stage. Its uses include after surgery, chemotherapy 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. “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.”