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510(k) Data Aggregation
(27 days)
SpaceOAR Vue System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR Vue System to reduce the radiation dose delivered to the anterior rectum.
The SpaceOAR Vue System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
The SpaceOAR Vue System consists of components for the preparation of an absorbable hydrogel spacer and a delivery mechanism packaged in a single use system. Upon injection, between the anterior rectal wall and prostate, the precursor (trilysine buffer solution with PEG-SG-TIB) and accelerator (a buffered solution) mix in the device Y-connector where the formation of SpaceOAR Vue hydrogel is initiated. The SpaceOAR Vue hydrogel is formed through cross-linking of the polyethylene glycol with succinimidyl glutarate and triiodobenzoate (PEG-SG-TIB) and Trilysine. This reaction gives off no measurable heat. The hydrogel temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR Vue System to reduce the radiation dose delivered to the anterior rectum. The hydrogel is biodegradable and maintains space for the entire course of prostate radiotherapy treatment. The hydrogel degrades via hydrolysis and is excreted via renal filtration.
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