Clinical Data
Clinical Data
SpaceOAR Vue Hydrogel: The Next-Generation Radiopaque Hydrogel Spacer
Summarized findings of adding the potential for CT visibility to SpaceOAR Vue Hydrogel is anticipated to expand hydrogel accessibility for patients who cannot undergo MRI, eliminate dependence on MRI for hydrogel contouring, assist in daily IGRT, and further improve the convenience of hydrogel placement.”SpaceOAR Vue™ Hydrogel: The Next-Generation Radiopaque Hydrogel SpacerRandall J. Brenneman, M.D., Ph.D., and Brian C. Baumann, M.D., Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri, United States
Supporting clinical summaries for SpaceOAR and SpaceOAR Vue
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Disclaimers:
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 and SpaceOAR Vue Hydrogels. Potential complications associated with SpaceOAR and SpaceOAR Vue Hydrogels include, but are not limited to: pain associated with SpaceOAR and SpaceOAR Vue Hydrogels injection, pain or discomfort associated with SpaceOAR and SpaceOAR Vue Hydrogels, local inflammatory reactions, infection (including abscess), urinary retention, urgency, constipation (acute, chronic, or secondary to outlet obstruction), rectal tenesmus/muscle spasm, mucosal damage, ulcers, fistula, perforation (including prostate, bladder, urethra, rectum), necrosis, allergic reaction (localised 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.
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 labelling 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