*Stereotactic body radiation therapy (SBRT) was not the method used in the single-blind Phase III trial performed to evaluate dosimetric and clinical effects of SpaceOAR Hydrogel. Image-guided Intensity Modulated Radiation Therapy (IG-IMRT) was the method used.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
Caution: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for use only in countries with applicable health authority registrations. This material not intended for use in France. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please check availability with your local sales representative or customer service.
Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary. BSC strongly recommends that you consult with your physician on all matters pertaining to your health or to address any questions.
As with any medical treatment, there are some risks involved with the use of SpaceOAR Hydrogel. Please talk with your doctor about the risks and benefits associated with the SpaceOAR. Potential complications associated with SpaceOAR Hydrogel include, but are not limited to: pain associated with SpaceOAR Hydrogel injection; pain or discomfort associated with SpaceOAR Hydrogel; needle penetration of the bladder, prostate, rectal wall, rectum or urethra; injection of SpaceOAR Hydrogel into the bladder, prostate, rectal wall, rectum or urethra; local inflammatory reactions; infection; injection of air, fluid or SpaceOAR Hydrogel intravascularly; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; and rectal urgency.
URO-709905-AA MAR 2020