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SpaceOAR Hydrogel animation.

SpaceOAR™ Hydrogel

Frequently Asked Questions on SpaceOAR™ Systems

Review common questions and answers on SpaceOAR Systems. If you're not finding an answer to your question, please contact our team for additional assistance.

Questions on clinical outcomes

SpaceOAR Hydrogel is an absorbable PEG-based hydrogel spacer clinically shown to help minimize the impact on urinary, sexual and bowel quality of life for patients undergoing radiation therapy for prostate cancer.1-3

SpaceOAR Hydrogel Systems are FDA cleared and intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer. In creating this space, it is the intent of SpaceOAR Hydrogel Systems to reduce the radiation dose delivered to the anterior rectum. 

SpaceOAR Hydrogel Systems are composed of a biodegradable material and maintain space for about 3 months during prostate radiotherapy treatment. The hydrogel liquifies and is absorbed by the body in about 6 months however, it may take longer to fully absorb.

Perirectal spacers have also been recommended as a pre-treatment option within the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).*

SpaceOAR Vue Hydrogel is the next-generation hydrogel that is designed to offer similar clinical benefits that SpaceOAR Hydrogel provides.

Questions on product and procedure

SpaceOAR Vue Hydrogel contains iodine which offers enhanced visibility via CT scan. The radiopacity is designed to help physicians improve contouring accuracy and may provide a suitable imaging option to MRI for patients with implanted metallic devices.

Both SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel consist mostly of water (90%) and polyethylene glycol (PEG) that, when combined, form a soft gel material. PEG materials in general have undergone extensive biocompatibility and safety testing and are used in a broad number of other implants such as surgical sealants for the eye, cranium and spine.

The SpaceOAR Vue product contains iodine. 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. 

SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel do not have any contraindications.

SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel can be implanted as an outpatient procedure in a hospital, surgery center, outpatient clinic or doctor’s office prior to the start of radiation treatment. It is typically not a lengthy process.

The procedure is often done in conjunction with fiducial marker placement. SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel are placed through the skin of the perineum using an 18-gauge needle and sit in the perirectal fat between the prostate and the rectum.

SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel stay in place for approximately 3 months, at which point the gel starts to break down, until the hydrogel is absorbed at about 6 months however, it may take longer to fully absorb. 

SpaceOAR Vue Hydrogel is a next-generation hydrogel spacer that offers enhanced visibility on a CT scan. SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel can be visualized on a T2 weighted MRI.

Yes, visibility of SpaceOAR Vue on a kV cone-beam CT is designed to aid in visualization of the target region enabling appropriate patient positioning for radiation treatment.

Both SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel are intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer. In creating this space, it is the intent of SpaceOAR Hydrogel Systems to reduce the radiation dose delivered to the anterior rectum. SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel are not indicated for any other cancer at this time.

SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel have a shelf life of 2 years.

For this procedure, a real time bi-plane transrectal ultrasound, a stepper, and a syringe containing saline are required; a stand-off balloon is recommended.

Perirectal spacing systems: Know the facts

     

SpaceOAR™ Hydrogel Systems

Hyaluronic Acid

Product material

Polyethylene glycol (PEG) - based

  • SpaceOAR Vue Hydrogel contains 1% iodine

Non-animal hyaluronic acid sourced from the fermentation of streptococcus4

Needle placement confirmation

Hydrodissection is required and can help confirm proper needle positioning and allows visualization of where the spacer will be injected

No hydrodissection is specified; dissection is a small bolus of hyaluronic acid5

Absorption

Per IFU, the hydrogel spacer maintains for approximately 3 months and is absorbed in about 6 months however, it may take longer to fully absorb.

57.2% loss by 12 months
73.6% loss at 18 months4

Clinical support

~375 publications, multiple clinical studies completed

~30 publications, 6-month follow-up pivotal trial data published FEB 20236

CT visibility
(only applicable to SpaceOAR Vue Hydrogel)

In one study, shown to remain visible on CT over the course of treatment7

  • The radiopacity may provide a suitable imaging option to MRI for patients with implanted metallic devices

Perirectal spacers that do not contain radiopaque material may make it more difficult to see on CT

       

Questions on reimbursement

Yes, the procedure for placing SpaceOAR Hydrogel products is currently covered by Medicare across the United States, as well as by several private insurance providers. Health insurance providers may require additional information to help them understand the procedure and technology. Payment varies by geographic locale.

SpaceOAR Hydrogel Coding & Payment quick reference guide >

Boston Scientific also has a team dedicated to supporting SpaceOAR Hydrogel coverage and reimbursement.  Our Urology Procedure Access Program can assist you with benefit verifications, pre-authorizations, as well as authorization and claim denials.

For additional information please visit: Benefit Verification and Pre-Authorization >

All payers require Category I CPT® code 55874 for SpaceOAR Hydrogel under descriptor: Transperineal placement of biodegradable material, peri-prostatic, single or multiple injection(s), including image guidance, when performed.

SpaceOAR Hydrogel Coding & Payment quick reference guide >

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SpaceOAR Systems Indications, Safety, and Warnings

*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer, V.1.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed September 16, 2022. To view the most recent and complete version of the guideline, go to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

NCCN=National Comprehensive Cancer Network® (NCCN®) 

References

  1. Hamstra DA, Mariados N, Sylvester J, et al. Continued benefit to rectal separation for prostate radiation therapy: final results of a phase III trial. Int J Radiat Oncol Biol Phys. 2017 Apr;97(5):976–85.
  2. Hamstra DA, Mariados N, Sylvester J, et al. Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: secondary analysis of a phase 3 trial. Pract Radiat Oncol. 2018 Jan-Feb;8(1):e7–e15.
  3.  Mariados N, Sylvester J, Shah D, et al. Hydrogel spacer prospective multicenter randomized controlled pivotal trial: dosimetric and clinical effects of perirectal spacer application in men undergoing prostate image guided intensity modulated radiation therapy. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):971–7.
  4. US Food and Drug Administration. 510(k) Summary for Barrigel® Injectable Gel. 2022. www.accessdata.fda.gov/cdrh_docs/pdf22/K220641.pdf. Accessed February 14, 2023.
  5. Barrigel® Injectable Gel Instructions for Use. 2022. barrigelsecure.s3.us-east-2.amazonaws.com/ifu/Barrigel-IFU-current.pdf. Accessed September 7, 2022.
  6. Mariados NF, Orio PF III, Schiffman Z, et al. Hyaluronic acid spacer for hypofractionated prostate radiation therapy: a randomized clinical trial. JAMA Oncol. 2023 Feb 9. Online ahead of print.
  7. Repka MC, Creswell M, Lischalk JW, et al. Rationale for utilization of hydrogel rectal spacers in dose escalated SBRT for the treatment of unfavorable risk prostate cancer. Front Oncol. 2022 Mar 31;12:860848.

Health economic and reimbursement information provided by Boston Scientific Corporation is gathered from third-party sources and is subject to change without notice as a result of complex and frequently changing laws, regulations, rules, and policies. This information is presented for illustrative purposes only and does not constitute reimbursement or legal advice. Boston Scientific encourages providers to submit accurate and appropriate claims for services. It is always the provider’s responsibility to determine medical necessity, the proper site for delivery of any services, and to submit appropriate codes, charges, and modifiers for services rendered. It is also always the provider’s responsibility to understand and comply with Medicare national coverage determinations (NCD), Medicare local coverage determinations (LCD), and any other coverage requirements established by relevant payers which can be updated frequently. Boston Scientific recommends that you consult with your payers, reimbursement specialists, and/or legal counsel regarding coding, coverage, and reimbursement matters. Boston Scientific does not promote the use of its products outside their FDA-approved or FDA-cleared label. Information included herein is current as of November 2025 but is subject to change without notice. Rates for services are effective January 1, 2026. 

CPT® Disclaimer

Current Procedural Terminology (CPT) Copyright 2025 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions apply to government use. Fee schedules, relative value units, conversion factors, and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. All trademarks are the property of their respective owners.

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 labelling supplied with each device or at www.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.

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