- Data on file with Boston Scientific.
- Addendum A and Addendum B Updates. CMS.gov. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Addendum-A-and-Addendum-B-Updates. Accessed October 25, 2022.
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 or at IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.
IMPORTANT INFORMATION: These materials are intended to describe common clinical considerations and procedural steps for the use of referenced technologies but may not be appropriate for every patient or case. Decisions surrounding patient care depend on the physician’s professional judgment in consideration of all available information for the individual case.
Boston Scientific (BSC) does not promote or encourage the use of its devices outside their approved labeling. Case studies are not necessarily representative of clinical outcomes in all cases as individual results may vary.
Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
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-989810-AB
Dr. Collins, Dr. Brenneman, Dr. Baumann, and Dr. Fredman are Boston Scientific consultants and were compensated for their contributions. All images are the property of Boston Scientific. All trademarks are the property of their respective owners.
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