1. Data on file with Boston Scientific.
SpaceOAR Vue Hydrogel 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 Hydrogel to reduce the radiation dose delivered to the anterior rectum.
SpaceOAR Vue Hydrogel contains polyethylene glycol (PEG) and iodine.
Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events.
As with any medical treatment, there are some risks involved with the use of SpaceOAR Vue Hydrogel. Potential complications associated with SpaceOAR Vue Hydrogel include, but are not limited to: pain associated with SpaceOAR Vue Hydrogel injection, pain or discomfort associated with SpaceOAR Vue Hydrogel, local inflammatory reactions, infection (including abscess), urinary retention, urgency, constipation (acute, chronic, or secondary to outlet perforation), rectal tenesmus/muscle spasm, mucosal damage, ulcers, fistula, perforation (including prostate, bladder, urethra, rectum), necrosis, allergic reaction (localized or more severe reaction, such as anaphylaxis), embolism (venous or arterial embolism is possible and may present outside of the pelvis, potentially impacting vital organs or extremities), syncope and bleeding. The occurrence of one or more of these complications may require treatment or surgical intervention. URO-989608-AB MAR 2022
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
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