OARtrac Radiation Dose Monitoring System Gets Expanded FDA Clearance for Electron Radiation Therapy

AngioDynamics Inc., a provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease and oncology, said the U.S. Food and Drug Administration (FDA) granted an expanded 510(k) clearance for the OARtrac Radiation Dose Monitoring System.
 
The additional indications clear the OARtrac System for use with patient-specific, pre-calibrated Plastic Scintillating Detector (PSD) sensors used during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning. The OARtrac System allows clinicians to measure and validate radiation doses targeted to a specific area of a patient’s body, allowing for more accurate and informed dosing.
 
The OARtrac System was previously cleared for use in the real-time monitoring and measurement of photon radiation and high dose rate (HDR) brachytherapy during cancer treatments on both the skin surface and with endorectal balloon (ERB) applications. The expanded Indication for Use now provides radiation oncologists and medical physicists with a tool to monitor and measure radiation doses in patients who receive electron radiation therapy, one of the most common radiotherapy treatments.
 
The system is also indicated for use with photon and electron energy when adhered to the skin or inserted into the rectum, allowing physicians to utilize a specifically designed OARtrac endorectal balloon device to take measurements at the rectal wall during cancer treatment.
 
“This expanded clearance provides us the opportunity to address an unmet need for patients in three of the most common types of radiation therapy, allowing for significantly improved outcomes,” said Brent Boucher, senior vice president for Oncology at AngioDynamics. “OARtrac is the type of disruptive technology that our customers value, and our team will continue to focus on creating additional pathways to help clinicians deliver the best possible treatment for their patients.”
 
AngioDynamics added the OARtrac System to its growing Oncology portfolio in 2018 when it acquired RadiaDyne and its balloon stabilizing technologies. The OARtrac System is a first-of-its-kind, patented, radiation dose monitoring technology that provides precise, real-time measurement via a proprietary intracavitary device. The system delivers critical dose feedback to medical and radiation oncologists, providing customized adaptive radiotherapy, reduced side effects, and improved clinical outcomes across the three most common types of radiation therapy: photon, electron, and HDR brachytherapy.
 
AngioDynamics Inc. provides minimally invasive medical devices used by professional healthcare providers for vascular access, peripheral vascular disease, and oncology. AngioDynamics’ diverse product lines include market-leading ablation systems, fluid management systems, vascular access products, angiographic products and accessories, drainage products, thrombolytic products and venous products.