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BioXmark is indicated for use to radiographically mark lung, bladder and lymph nodes in adult patients for whom it has been determined that radiographical marking of tissue for radiation treatment is indicated for their cancer treatment. BioXmark is implanted via image guided injection into tissue relevant for radiotherapy planning at a healthcare facility. BioXmark can be implanted in the tumor, lymph nodes or tissue adjacent to the tumor subject to irradiation or healthy tissue which should not be irradiated. BioXmark is intended to mark tissue for at least 3 months after implantation.

The device is a single-use, implantable device consisting of a sterile transparent liquid in a onepoint-cut (OPC) glass ampoule. Upon injection of the liquid into soft tissue, efflux of alcohol leads to the formation of a radiopaque, sticky, gel-like fiducial marker in vivo, which is visible using fluoroscopy, CT. MRI, and ultrasound. The subject device is a mixture of ethanol, sucrose acetate isobutyrate (SAIB) and an iodinated and acylated derivative of sucrose (x-SAIB). Each ampoule contains 1 mL of liguid and is steam sterilized. On injection, a miniscule amount of ethanol diffuses in 1 to 2 hours, causing an increase in marker viscosity and resulting in a hydrophobic semisolid gel-like marker at the injection site.