Spacer system designed to protect men undergoing PCa radiotherapy
Waltham, MA—Augmenix, Inc. announced FDA clearance of the SpaceOAR System, which the company said is the first product in the U.S. to be cleared as a spacer to protect the rectum in men undergoing prostate cancer radiotherapy. The SpaceOAR System, a hydrogel product, is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy, creating space to protect the anterior rectum from radiation exposure. Placed through a small needle, the hydrogel is administered as a liquid, but quickly solidifies into a soft gel that expands the space between the prostate and rectum. The hydrogel spacer maintains this space until radiotherapy is complete. The spacer then liquefies and is absorbed and cleared from the body in the patient’s urine.
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