SpaceOAR™ SystemSpaceOAR™ Absorbable Perirectal Hydrogel Spacer
SpaceOAR 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 System to reduce the radiation dose delivered to the anterior rectum.
The SpaceOAR 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.
SpaceOAR Hydrogel is an absorbable, polyethylene glycol (PEG)-based, injectable material that temporarily creates space between the rectum and prostate in patients undergoing radiation therapy for prostate cancer.1
Certified applier program
We utilize a formal certification process for all new users, proctoring thousands of cases annually to ensure optimal patient outcomes. To become certified in the application of SpaceOAR Hydrogel, physicians must complete the following necessary steps.
- Hands-on desktop demonstration of product setup & application by a certified SpaceOAR Hydrogel representative.
- Review SpaceOAR Hydrogel System Application Physician Training Module with a certified SpaceOAR Hydrogel representative.
- Complete multiple cases under guidance of a certified SpaceOAR Hydrogel representative, and demonstrate competency to successfully complete the SpaceOAR Hydrogel application independently.
1. Data on file with Boston Scientific.
SpaceOAR 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 Hydrogel to reduce the radiation dose delivered to the anterior rectum.
SpaceOAR Hydrogel contains polyethylene glycol (PEG).
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 Hydrogel. 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, 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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