SpaceOAR™ Systems

SpaceOAR and SpaceOAR Vue Systems 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 the SpaceOAR and SpaceOAR Vue Systems to reduce the radiation dose delivered to the anterior rectum.  

The SpaceOAR and SpaceOAR Vue Systems are composed of biodegradable material and maintain space for the entire course of prostate radiotherapy treatment and are completely absorbed by the patient’s body over time. 

None known.

Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout these and other instructions relevant to the procedure. Failure to do so may result in complications.  

• SpaceOAR and SpaceOAR Vue System must only be administered via an aseptic transperineal route. Do not administer transrectally.  
• The SpaceOAR and SpaceOAR Vue needle tip must be at the prostate midline during SpaceOAR and SpaceOAR Vue hydrogel injection to avoid lateral hydrogel formation. In the US Clinical Study incorrect hydrogel placement was observed in 0.7% of subjects.  
• The SpaceOAR and SpaceOAR Vue needle should be inserted under ultrasound guidance to maintain needle tip visibility and prevent rectal wall penetration. In the US Clinical Study inadvertent rectal wall needle penetrations were experienced in 1.4% of subjects.  
• If the needle enters the rectal lumen at any time during the procedure, abandon the procedure to avoid infection.  
• Scar tissue or adhesions within the perirectal space (from prior biopsies, prior prostate surgery or trauma for example) may prevent the perirectal space from opening during hydrodissection. If the perirectal space does not open with saline, do not inject SpaceOAR or SpaceOAR Vue.  
• If SpaceOAR or SpaceOAR Vue hydrogel is not seen in the perirectal space during injection, discontinue the procedure immediately. This could potentially indicate gel is in an unintended location (blood vessel). Do not inject additional SpaceOAR or SpaceOAR Vue.  
• Injection of air, fluid, SpaceOAR, or SpaceOAR Vue hydrogel intravascularly could potentially lead to arterial or venous embolism. Always aspirate with the saline syringe to verify the needle tip is not in a blood vessel. If blood is aspirated, discontinue the procedure.  
• The SpaceOAR and SpaceOAR Vue products contain PEG. The use of this product in patients with documented PEG sensitivities or allergies has not been studied. The use of SpaceOAR or SpaceOAR Vue in patients with a known allergy to PEG could potentially lead to allergic reaction (including anaphylaxis). 
• The safety and performance of SpaceOAR or SpaceOAR Vue in patients that have previously undergone pelvic radiation has not specifically been studied. Previous radiation may result in scarring and ischemia in the perirectal space. Placement of a spacer in this patient population may result in an increased risk of fistula. Since the risk of using SpaceOAR or SpaceOAR Vue in these patients is unknown, physicians considering using the product in this setting must carefully consider the potentially higher risk of fistula for these patients in deciding how to manage their radiation treatment. 

• SpaceOAR and SpaceOAR Vue Hydrogel System procedures should only be performed by physicians who have received or are undergoing appropriate training for proper hydrogel spacer deployment technique.  
• Users of SpaceOAR and SpaceOAR Vue System should be familiar with ultrasound needle placement during transperineal procedures.  
• Use caution when attaching the powder vial to the sharp vial adapter component to avoid injury.  
• The SpaceOAR and SpaceOAR Vue System is provided sterile.  
• Do not use if the PEG powder is not free flowing.  
• All SpaceOAR and SpaceOAR Vue System components are intended for single-use only. SpaceOAR and SpaceOAR Vue System components cannot be re-used.  
• Use only with delivery system provided. Appropriate mixing of the Precursor and Accelerator solutions will not occur if the supplied Y-Connector is not used.  
• Use within 1 hour of preparing the Precursor solution. Discard entire system if not used within 1 hour.  
• If placing fiducials, do so with a transperineal approach prior to SpaceOAR or SpaceOAR Vue hydrogel injection.  
• SpaceOAR and SpaceOAR Vue System injection should proceed uninterrupted, without stopping. Stopping during injection may result in device plugging, requiring the preparation of a replacement system.  
• Air resulting from the SpaceOAR or SpaceOAR Vue injection may distort ultrasound image.  
• Maintain visualization of the SpaceOAR and SpaceOAR Vue needle tip at all times to prevent injecting SpaceOAR and SpaceOAR Vue into an unintended location, including the rectal wall, prostate, blood vessels, or other tissues. If needle tip visibility is distorted or compromised, do not inject SpaceOAR or SpaceOAR Vue.  
• Excessive resistance experienced during hydrodissection, SpaceOAR, or SpaceOAR Vue injection may indicate the needle tip is in an unintended location. Reassess needle position.  
• SpaceOAR Vue: The SpaceOAR Vue product contains an iodinated compound. The use of this product in patients with documented iodine sensitivities or allergies has not been extensively studied. The risks and benefits of the decision to use in patients with a documented iodine allergy should be carefully considered on a case-by-case basis. 
• Limit needle movement after hydrodissection and during SpaceOAR or SpaceOAR Vue injection to avoid perforating unintended organs, such as the rectal wall, prostate, or blood vessels.  

Potential complications that may be associated with the use of SpaceOAR or SpaceOAR Vue System include, but are not limited to:  

• Pain associated with SpaceOAR or SpaceOAR Vue hydrogel injection  
• Pain or discomfort associated with SpaceOAR or SpaceOAR Vue hydrogel  
• Local inflammatory reactions  
• Infection (including abscess)  
• Urinary retention  
• Urgency (e.g. urinary and rectal)  
• 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 (includes 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 (ranging from transient loss of consciousness to events requiring cardiovascular resuscitative measures). 
• Bleeding  

The occurrence of one or more of these complications may require treatment or surgical intervention.