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SpaceOAR System

Because of the close proximity of the prostate to the rectum, prostate radiation therapy typically results in some radiation hitting the rectum, which can sometimes cause side effects. The SpaceOAR® System creates space and pushes the rectum away from the prostate and the high dose area. 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 radiation therapy is complete. The spacer then liquefies and is absorbed and cleared from the body in the patient’s urine.

According to the American Cancer Society and the National Cancer Institute, prostate cancer is second only to skin cancer as the most frequently diagnosed cancer in men with an estimated 220,800 new cases and 27,540 deaths in the U.S. in 2017 alone. Worldwide, prostate cancer is expected to grow to 1.7 million new cases and 499,000 deaths by 2030.

FDA clearance was granted following completion of the SpaceOAR® System prospective, multicenter, randomized clinical trial. SpaceOAR® patients experienced a significant reduction in rectal radiation dose and severity of late rectal toxicity when compared to control patients who did not receive SpaceOAR® hydrogel. The full pivotal clinical trial results have been accepted for publication in a peer-reviewed journal and are expected to be published soon.