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510(k) Data Aggregation
(135 days)
OncoPatch is indicated for the surface treatment of localized tumors. It is designed to deliver radiation therapy for the treatment of superficial lesions. It can be used either as primary treatment or as treatment for residual disease after excision of primary or recurrent tumors.
The OncoPatch device is engineered for the surface treatment of skin cancers, such as basal and squamous cell carcinoma, as well as for other skin conditions, including keloids. Using yttrium-90 (Y-90) as the radioactive source, this device delivers low-energy beta radiation directly to the skin surface, targeting cancerous or abnormal tissue while sparing underlying healthy tissue. The OncoPatch device makes use of radioactive patches constructed from thin, polymer-coated foils containing Y-90. These foils are adhered to the underside of a plastic or metal composite shield, which ensures safety for both the patient and healthcare providers during treatment. The patch and shield are coupled with an applicator. The applicator uses collimators with predetermined shapes and sizes that assume a flat patient geometry. The OncoPatch is secured temporarily to the patient surface for single or multiple treatment fractions, typically with short (< 60 min) treatment durations.
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