The only FDA 510k Cleared sheet device on the market.
The implantable CivaSheet® low dose rate (LDR) source is the only membrane-like brachytherapy device that is truly customizable to a specific patient’s condition and offers a unidirectional option to shield healthy tissue. For the first time, radiation oncologists have a configurable, planar LDR array that offers dose distribution on one side.
CivaSheet features a flexible, bioabsorbable substrate embedded with radioactive palladium, available custom-shielded to provide unidirectional radiation emission, that can also be custom-sized within the operating room. Integrative shielding offers clinicians the ability to treat cancerous tissue while also protecting surrounding healthy tissue.
Physicians have used the CivaSheet for numerous indications such as colorectal, gynecological, head and neck, soft tissue sarcomas and pancreatic cancer. Potential indications include non-small-cell lung cancer, ocular melanoma, atypical meningioma, etc.
CivaSheet received FDA 510(k) clearance in August 2014.
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