Accuray Receives FDA 510(k) Clearance for its VitalHold™ on the Radixact® System

Madison, WI (10 August 2023) — Accuray Incorporated has announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VitalHold™* breast package on the Radixact^® System. The treatment option will also be available in the EU market. VitalHold facilitates deep inspiration breath hold (DIBH) treatments using the Radixact System’s fixed beam angle delivery mode (TomoDirect™) and a fully integrated and automated surface-guided radiation therapy (SGRT) solution, featuring the Catalyst+ HD system from C-RAD. With the addition of this new functionality, the Radixact System offers a comprehensive tool set for the treatment of breast cancer. The VitalHold technology will be available to customers in the United States and European Union as well as other regions, subject to regulatory clearance or approvals.

DIBH treatments are often used to help minimize radiation dose to organs at risk (OARs) and reduce associated complications later in life. During treatment, a patient takes a deep breath which moves the heart away from the chest wall and the targeted tumor. The SGRT tracking system continuously monitors a patient’s breathing and position with cameras to confirm the patient is appropriately positioned to deliver radiation. SGRT is designed to enable medical care teams to effectively position the patient and confidently monitor the accuracy of that positioning throughout 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,” said Suzanne Winter, President and CEO of Accuray.

“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.”

The CT linac based Radixact System offers multiple radiation delivery options to tailor each patient’s treatment based on their specific needs. The system’s extensive capabilities make it possible for clinicians to treat breast cases in as little as 2 minutes. With TomoHelical™ mode, the Radixact System continuously delivers radiation beams from 360 degrees around the patient, enabling the treatment of complex cases, such as cancer in the breast and surrounding lymph nodes. This approach also provides a valuable option for patients who are unable to hold their breath, which is key to undergoing DIBH treatments. TomoDirect mode facilitates delivery of radiation from specific fixed angles.

According to the National Cancer Institute, breast cancer is the most common cancer diagnosed in women in the U.S., other than skin cancers¹. Radiation therapy plays a crucial role in the management of early-stage, locally advanced, and metastatic breast cancer cases. It is utilized in approximately 87 percent of breast cancer patients²  and accounts for more than 25 percent of cases in most radiation therapy departments³.

The Radixact^® System with its unique radiation delivery approaches offers advantages in the treatment of breast cancer including the ability to deliver precise radiation dose to any tumor bed, during every treatment, while minimizing dose to nearby healthy organs and tissues. With the Radixact System, radiation therapy may be an option for treating breast cancer at almost every stage and can be used after surgery, chemotherapy and other medications.

*VitalHold™ availability is subject to regulatory clearance or approval in some markets.

¹ https://www.cancer.gov/types/breast
² Shah C et al (2021) Advances in Breast Cancer Radiotherapy: Implications for Current and Future Practice. JCO Oncol Pract. 2021 Dec;17(12):697-706. doi: 10.1200/OP.21.00635. Epub 2021 Oct 15. PMID: 34652952.
³ Harnett A (2010) Fewer fractions of adjuvant external beam radiotherapy for early breast cancer are safe and effective and can now be the standard of care. Why the UK’s NICE accepts fewer fractions as the standard of care for adjuvant radiotherapy in early breast cancer. Breast. 2010 Jun;19(3):159-62. doi: 10.1016/j.breast.2010.03.029. Epub 2010 Apr 24. PMID: 20456956.