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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 Systems are absorbable PEG-based hydrogel spacers clinically shown to help minimize the impact on urinary, sexual and bowel quality of life for patients undergoing radiation therapy.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. The SpaceOAR Hydrogel Systems are composed of a biodegradable material and maintain space for the prostate radiotherapy treatment and are absorbed by the patient’s body in approximately 6 months.

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.4

Questions on product and procedure

SpaceOAR Vue Hydrogel contains PEGylated Iodine which offers enhanced visibility via CT scan. The radiopacity is designed to help physicians improve contouring accuracy, streamline workflow by reducing the need for a second MRI or an MRI-CT fusion, and may provide a suitable imaging option to MRI for patients with implanted metallic devices.

SpaceOAR Vue Hydrogel may be used in patients with iodine sensitivity when carefully considered on a case-by-case basis.

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.4

SpaceOAR Vue Hydrogel is a next-generation hydrogel spacer that offers enhanced visibility on a CT scan. SpaceOAR Hydrogel can be visualized on a T2 weighted MRI.4

Yes, persistent 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 as a pre-treatment to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer.4 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 as a pre-treatment for any other cancer at this time.

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

A stepper/stabilizer stand and an ultrasound equipped with a real-time bi-plane transrectal probe are required for SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel procedures.1

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 streptococcus⁵

Needle placement confirmation

Hydrodissection can 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 acid⁶

Absorption

Per IFU, the hydrogel spacer maintains for approximately 3 months and is absorbed in about 6 months⁴

57.2% loss by 12 months
73.6% loss at 18 months⁵

Clinical support

~300 publications, multiple clinical studies completed⁴

25 publications, 6-month follow-up pivotal trial data published FEB 2023⁷

CT visibility
(only applicable to SpaceOAR Vue™ Hydrogel)

In one study, shown to remain visible on CT over the course of treatment⁸

  • May streamline workflow by eliminating the need to preauthorize additional MRI⁴
  • No need to fuse MRI and CT images, plan using CT only⁴
  • The radiopacity may provide a suitable imaging option to MRI for patients with implanted metallic devices⁴

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

       

SpaceOAR Vue Hydrogel CT scan placed October 2022. Patient X SpaceOAR Vue Hydrogel Placed OCT 2022
Hyaluronic acid CT scan placed October 2022. Patient Y Hyaluronic Acid Placed OCT 2022

Notes: Both rectal spacers were placed by the same physician at the same clinic. Both images are CT images.

Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.

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 >

Download the national commercial coverage document

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 System Indications, Safety, and Warnings
SpaceOAR Vue 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. Data on file with Boston Scientific.
  5. 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.
  6. Barrigel® Injectable Gel Instructions for Use. 2022. barrigelsecure.s3.us-east-2.amazonaws.com/ifu/Barrigel-IFU-current.pdf. Accessed September 7, 2022.
  7. 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.
  8. 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 label. Information included herein is current as of November 2022 but is subject to change without notice. Rates for services are effective January 1, 2023.

Payer policies will vary and should be verified prior to treatment for limitations on diagnosis, coding, or site of service requirements.

The coding options listed within this guide are commonly used codes and are not intended to be an all-inclusive list. We recommend consulting your relevant manuals for appropriate coding options.

CPT® Disclaimer

Current Procedural Terminology (CPT) Copyright 2022 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.

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.

SpaceOAR and SpaceOAR Vue Hydrogels contain polyethylene glycol (PEG). SpaceOAR Vue Hydrogel contains 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 perforation), rectal tenesmus/muscle spasm, mucosal damage, ulcers, fistula, perforation (including prostate, bladder, urethra, rectum), necrosis, allergic reaction (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 and bleeding. The occurrence of one or more of these complications may require treatment or surgical intervention. URO-989811-AB.

All images are the property of Boston Scientific. All trademarks are the property of their respective owners.