Radiopaque Perirectal Spacer for Radiation Therapy
SpaceOAR Vue Hydrogel Application Procedure
- Side-fire (biplane) transrectal ultrasound (TRUS) probe
- Stepper stabilizer
- Bowel prep
- Prophylactic antibiotics (recommended)
- Lithotomy position
- Anesthesia (as needed)
- Perineal skin prep
- Attach provided 18G needle to an injectable saline-filled 10cc syringe
- Advance needle tip to midgland perirectal fat; check in axial view to ensure needle tip is midline for optimal placement
- Slowly inject saline to expand (hydrodissect) perirectal space
- Aspirate to ensure needle is not intravascular
SpaceOAR Vue Hydrogel injection
- Keeping the 18G needle in place, remove saline syringe and attach SpaceOAR Vue Hydrogel applicator
- Inject hydrogel without stopping or pausing
- Remove and dispose of needle
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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.
SpaceOAR and SpaceOAR Vue Hydrogels are 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 and SpaceOAR Vue Hydrogels to reduce the radiation dose delivered to the anterior rectum.
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; needle penetration of the bladder, prostate, rectal wall, rectum or urethra; injection of SpaceOAR and SpaceOAR Vue Hydrogels into the bladder, prostate, rectal wall, rectum or urethra; local inflammatory reactions; infection; injection of air, fluid or SpaceOAR and SpaceOAR Vue Hydrogels intravascularly; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; and rectal urgency.
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