The VitalHold breast package facilitates deep inspiration breath hold (DIBH) treatments using TomoDirect treatment delivery mode on the Radixact System, through a fully integrated and automated surface-guided radiation therapy (SGRT) solution

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FDA approves new functionality on Radixact System. (Credit: Michal Jarmoluk from Pixabay)

US-based medical equipment manufacturer Accuray has received the US Food and Drug Administration (FDA) 510(k) approval for a new breast cancer treatment functionality, VitalHold, on the Radixact System.

The VitalHold breast package facilitates deep inspiration breath hold (DIBH) treatments using TomoDirect treatment delivery mode on the Radixact System.

It delivers the DIBH treatments through a fully integrated and automated surface-guided radiation therapy (SGRT) solution that features the Catalyst+ HD system from C-RAD.

The VitalHold functionality makes Radixact System a comprehensive tool set for breast cancer treatment, enabling high breast cancer throughput for clinics.

Accuray will offer the VitalHold technology to customers in the US and EU, along with other regions, subject to regulatory approvals.

Accuray president and CEO Suzanne Winter said: “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.”

According to the US medical device maker, DIBH treatments are used to minimise radiation dose to organs at risk (OARs) and reduce the associated complications later in life.

The DIBH treatments require the patients to take a deep breath, which moves the patients’ heart away from the chest wall and the targeted tumour.

Radixact System leverages SGRT tracking to continuously monitor a patient’s breathing and position to confirm whether the patient is properly positioned to deliver radiation.

SGRT is designed to enable medical care teams to effectively position the patient and monitor the accuracy of that positioning throughout treatment.

The Radixact System offers multiple radiation delivery options to customise the treatment based on specific needs and enables clinicians to treat the cases within two minutes.

In addition to the TomoDirect, the system also offers TomoHelical mode that enables continuous delivery of radiation beams from 360 degrees around the patient, said Accuray.