FDA Approval Granted To Accuray: Vitalhold™ Incorporated Into Radixact® System, Widening Therapeutic Possibilities For Breast Cancer

Thursday, August 10, 2023

Accuray Incorporated has achieved a significant milestone by obtaining 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the integration of its innovative VitalHold™* breast package into the Radixact® System. This breakthrough treatment avenue is also set to expand its availability within the European market. The groundbreaking VitalHold™ technology was meticulously designed to optimize deep inspiration breath hold (DIBH) treatments, harnessing the Radixact System's fixed beam angle delivery mode, known as TomoDirect™. With the addition of an automated surface-guided radiation therapy (SGRT) solution, powered by C-RAD's Catalyst+ HD system, the Radixact System is now equipped with a comprehensive toolkit for effectively addressing breast cancer.

At the core of this advancement lies the VitalHold™ system's ability to synchronize with the patient's breathing cycle, orchestrating a harmonious rhythm between breaths and radiation delivery. By guiding patients to take deep inhalations, the heart is gently displaced from the chest wall, creating a safer path for precisely targeting the tumor. The vigilant SGRT tracking system, equipped with advanced cameras, ensures consistent patient positioning and treatment accuracy.

Enhanced by this innovation, the Radixact® System introduces a new era in the holistic treatment of breast cancer. It offers a wide range of therapeutic possibilities that clinicians can tailor to each patient's unique needs. Particularly noteworthy is the system's capacity to emit radiation from all directions around the patient, covering a complete 360-degree spectrum, which expands its capabilities to address complex cases involving the breast and adjacent lymph nodes.

This achievement is particularly noteworthy for its inclusivity, accommodating patients who may encounter challenges in adhering to the breath-hold technique—a crucial aspect of DIBH treatments. Moreover, the TomoDirect mode enhances the precision and flexibility of radiation delivery by targeting specific angles with meticulous accuracy.

The Radixact® System's distinctive approach seamlessly aligns with the intricacies of breast cancer treatment. It showcases its precision by sculpting the radiation dose with exactness, honing in on the tumor while sparing surrounding healthy tissues from undue exposure.

This remarkable innovation propels radiation therapy into a prominent role in the management of breast cancer across various stages and in conjunction with different therapeutic modalities, including surgery, chemotherapy, and other medications. As Accuray embarks on this pioneering journey, the Radixact System stands as a testament to the convergence of cutting-edge technology and an unwavering commitment to enhancing patient care.


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