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Brief Summary Document — HCP
Intended use/Indications for use
SpaceOAR 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 SpaceOAR Systems to reduce the radiation dose delivered to the anterior rectum.
The SpaceOAR Systems are composed of a biodegradable material that maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient’s body over time.
Contraindications
There are no known contraindications.
Warnings
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.
| Product | |||
| SpaceOAR | SpaceOAR Vue | SpaceOAR Flex | |
| The SpaceOAR System must only be administered via an aseptic transperineal route. Do not administer transrectally. | X | X | X |
| If the needle enters the rectal lumen at any time during the procedure, abandon the procedure to avoid infection. | X | X | X |
| 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 System hydrogel. Failure to hydrodissect and confirm needle positioning within the opened perirectal space may lead to hydrogel injection into an unintended location. | X | X | X |
| If SpaceOAR System hydrogel is not seen in the perirectal space during injection, discontinue the procedure immediately. This could potentially indicate hydrogel is in an unintended location (blood vessel). Do not inject additional SpaceOAR System hydrogel. | X | X | X |
| Injection of air, fluid, or SpaceOAR System 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. | X | X | X |
| SpaceOAR System hydrogels contain PEG. The use of these products in patients with documented PEG sensitivities or allergies has not been studied. The use of SpaceOAR System hydrogel in patients with a known allergy to PEG could potentially lead to allergic reaction (including anaphylaxis). | X | X | X |
| The safety and performance of SpaceOAR System 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 System in these patients is unknown, physicians considering using the products in this setting must carefully consider the potentially higher risk of fistula for these patients in deciding how to manage their radiation treatment. | X | X | X |
| 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. | X | X | |
| 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. | X | X | |
| The SpaceOAR Flex needle should be inserted under transrectal ultrasound guidance. Maintain visualization of the needle tip at all times to prevent injecting hydrogel 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 Flex hydrogel. Injection of the hydrogel into an unintended location may result in complications. | X | ||
| When injecting SpaceOAR Flex hydrogel, ensure hydrogel is applied at the base, mid-gland and apex as needed per the patient anatomy. Avoid injecting a bolus of hydrogel in one location. | X | ||
| Excessive resistance experienced during hydrodissection or hydrogel injection may indicate the needle tip is in an unintended location. Reassess and confirm needle tip is between the Denonvilliers’ fascia and anterior rectal wall. Not doing so may potentially result in hydrogel injection into an unintended location. | X | ||
| Always use axial view to maintain needle visibility when moving laterally or contralaterally. Stay within the lateral confines of the prostate (Figure 16 in the SpaceOAR Flex IFU) and within the barrier of the midline-sphere to avoid interaction of the needle with adjacent anatomy. Failure to maintain needle positioning within the defined spheres may lead to needle misplacement and subsequent hydrogel injection into an unintended location. | X | ||
| Use controlled needle movements after hydrodissection and during SpaceOAR Flex hydrogel injection to avoid perforating unintended organs, such as the rectal wall, prostate, or blood vessels. Perforation of adjacent anatomy may result in hydrogel injection into an unintended location. | X | ||
| Always hydrodissect and confirm the space between the Denonvilliers’ fascia and anterior rectal wall opens as intended. Failure to hydrodissect and confirm needle positioning within the opened perirectal space may lead to hydrogel injection into an unintended location. | X | ||
| After the injection of each sphere, verify the sphere is in the intended location using ultrasound imaging before injecting additional spheres. If at any time the sphere does not appear to be in the perirectal space, do not add additional hydrogel. Discontinue the procedure. | X | ||
Precautions
| Product | |||
| SpaceOAR | SpaceOAR Vue | SpaceOAR Flex | |
| SpaceOAR System procedures should only be performed by physicians who have received or are undergoing appropriate training for proper hydrogel spacer deployment technique. Contact Boston Scientific for more information. | X | X | X |
| Users of SpaceOAR System should be familiar with ultrasound needle placement during transperineal procedures. | X | X | X |
| All SpaceOAR System components are intended for single-use only. The SpaceOAR System components cannot be re-used. | X | X | X |
| Use only with delivery system and components provided. | X | X | X |
| If placing fiducials, do so with a transperineal approach prior to SpaceOAR System hydrogel injection. | X | X | X |
| Air resulting from the SpaceOAR System hydrogel injection may distort ultrasound image. | X | X | X |
| SpaceOAR Vue and SpaceOAR Flex hydrogel contain an iodinated compound. The use of these products in patients with documented iodine sensitivities or allergies has not been 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. | X | X | |
| The SpaceOAR and SpaceOAR Vue System is provided sterile. | X | X | |
| Use caution when attaching the powder vial to the sharp vial adapter component to avoid injury. | X | X | |
| Do not use if the PEG powder is not free flowing. | X | X | |
| 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. | X | X | |
| Use within 1 hour of preparing the Precursor solution. Discard entire system if not used within 1 hour. | X | X | |
| 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. | X | X | |
| Excessive resistance experienced during hydrodissection or SpaceOAR / SpaceOAR Vue injection may indicate the needle tip is in an unintended location. Reassess needle position. | X | X | |
| 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. | X | X | |
| On ultrasound, if you see rectal wall, Denonvilliers’ fascia, or nearby anatomy moving with needle tip on ultrasound, stop the procedure and realign needle tip inside perirectal fat plane. | X | ||
| The blue marking on the needle hub will be facing up and visible to the user when correctly oriented, with needle bevel facing down. Failure to orient the bevel, may result in loss of visualization of the needle and potential patient injury including, but not limited to discomfort, pain, perforation, and infection. | X | ||
| SpaceOAR Flex System is provided sterile. Do not use if packaging or seal has been damaged or opened. Do not re-sterilize. | X | ||
| Do not transfer hydrogel between syringes more than indicated in Steps 6 through 8 (in Device Preparation section of the SpaceOAR Flex IFU). Overmixing may result in excessive air bubbles which may affect the ultrasound image. | X | ||
| Minimize needle movement while exchanging the saline syringe with SpaceOAR Flex System syringe to avoid perforation of unintended organs, such as the rectal wall, prostate, or blood vessels. | X | ||
Adverse events
Potential complications that may be associated with the use of SpaceOAR Flex System include, but are not limited to:
- Pain associated with SpaceOAR System hydrogel injection
- Pain or discomfort associated with SpaceOAR System 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.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
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