SpaceOAR Vue™ Hydrogel illustration on a purple background.

SpaceOAR™ Systems

Perirectal Spacers for Prostate Cancer Radiation Therapy

Proven. Trusted. Visibly different.

New bench test: See how SpaceOAR compares

What is SpaceOAR Hydrogel?

SpaceOAR Hydrogel is a polyethylene glycol (PEG) based hydrogel designed to temporarily create space between the prostate and rectum, and reduce the radiation dose delivered to the rectum during radiation therapy.^1,2 It has been clinically shown to help reduce the side effects of radiation therapy on patient quality of life.²⁻⁴

Learn how it works

SpaceOAR Hydrogel has been shown to minimize the risk of bowel, urinary, and sexual side effects.^2–4

Fewer bowel complications

Bowel quality of life (QoL) was maintained at a rate of nearly 3 to 1 as compared to the control group at median 3 years³

Fewer urinary complications

Statistically significant lower incidence of grade 1 urinary incontinence (P=0.05)³ at 3 years
Significantly fewer patients had a 12-point (23% vs. 8%, P<.03) decline in urinary QoL³

Fewer sexual complications

67% maintained potency compared to 38% in control group at median 3 years*⁴

Explore the data

Why choose SpaceOAR Hydrogel?

Visibly different: SpaceOAR Vue™ Hydrogel is the only FDA-cleared radiopaque PEG-based perirectal hydrogel spacer designed for CT visibility

Proven: SpaceOAR Hydrogel is referenced in ~300 publications and reported in 3 systematic reviews and meta-analysis publications, including the SpaceOAR Hydrogel U.S. Pivotal Trial, that demonstrated space creation and reduction in dose delivered to the rectum during prostate cancer radiation therapy compared to control subjects not receiving a perirectal spacer^{1-2, 5-7}

Trusted: To date, 280,000 patients have been treated and that number is growing with SpaceOAR Hydrogel Portfolio — and SpaceOAR products have been purchased at 10 of the top 10 cancer centers^*†

SpaceOAR™ Hydrogel Systems Rheology Bench Study White Paper thumbnail.

Comparing Rheological Behavior of SpaceOAR Vue Hydrogel and Barrigel

Download the latest bench test comparing the rheological properties of SpaceOAR Vue™ and Barrigel® hydrogels. This bench test reveals how each hydrogel responds to stress. In this bench test performed by Boston Scientific, Barrigel showed a greater variability in volume change compared to SpaceOAR Vue Hydrogel at lower pressures (below 80 mmHg) and at higher pressures (above 80 mmHg).

Download the white paper

Get in touch with our team

Whether you’re looking to get started with SpaceOAR Hydrogel or have general questions about the product, procedure, or clinical data, our team is here to help.

We created this space together

When you choose SpaceOAR Hydrogel for your prostate cancer patients, you’re not only getting a device with proven clinical outcomes — you’re choosing a world-class customer experience.

2010–2012
• Augmenix SpaceOAR launches in the European Union (EU)
• One of the first publications utilizing SpaceOAR Hydrogel⁹
• SpaceOAR European Pilot Study^9,10
2014–2016
• SpaceOAR U.S. Pivotal Study
• Randomized control trial published²
• Augmenix SpaceOAR launches in U.S.
• Long-term follow-up of SpaceOAR U.S. Pivotal Study
2017
• 3-year clinical trial results published³
• National Institute for Health and Care Excellence (NICE) Interventional Procedures Programme: Interventional procedure overview of biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer
2018–2019
• Large Urology Group Practice Association – LUGPA^4,11,12
• CMS Initial Decision for Prostate Rectal Spacer Coverage¹⁴
• Category 1 CPT^® code goes into effect (2018)^**1
• Boston Scientific acquires SpaceOAR Hydrogel
• Boston Scientific SpaceOAR Vue launches in the U.S.
2020
• Boston Scientific SpaceOAR Vue launches in the EU
• Boston Scientific SpaceOAR launches in the EU
• Nationwide Medicare coverage achieved¹
• Recommended as a pre-treatment option within the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®)¹³
2021
• SpaceOAR Post Market Study – Japan
2023
• 280,000 SpaceOAR units shipped to date and growing¹
• ~300 SpaceOAR publications to date¹
• Used by physicians at top 10 of 10 U.S. cancer hospitals in 2023^‡,1
• 2,300+ physicians certified¹
• NICE recommendations/guidelines from Sept. 2022

What physicians are saying about SpaceOAR Hydrogel

For prostate cancer patients undergoing radiation therapy, maintaining quality of life may be just as important as treating the cancer.

SpaceOAR Hydrogel for prostate cancer

Dr. Marcio Fagundes, Radiation Oncologist, describes his experience using SpaceOAR Hydrogel including clinical considerations, impact on workflow, and his approach with patients.

Late rectal toxicity and how SpaceOAR Hydrogel helps

Dr. Sean Collins, Radiation Oncologist, discusses how SpaceOAR Hydrogel can help reduce late rectal toxicity in patients following radiation therapy.

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SpaceOAR Systems Indications, Safety, and Warnings

*Of men who had erections sufficient for intercourse at baseline.
†Number of patients is based on units shipped and a BSC proprietary algorithm.
‡Data based on sales for SpaceOAR™ Hydrogel or SpaceOAR Vue™ Hydrogel to institutions in 2022 and 2023
**CPT copyright © 2023 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

References

Data on file with Boston Scientific.
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;92:971–977.
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;97:976–985.
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;8:e7–e15.
Payne HA, Pinkawa M, Peedell C, Bhattacharyya SK, Woodward E, Miller LE. SpaceOAR hydrogel spacer injection prior to stereotactic body radiation therapy for men with localized prostate cancer: a systematic review. Medicine (Baltimore). 2021;100:e28111.
Armstrong N, Bahl A, Pinkawa M, et al. SpaceOAR Hydrogel spacer for reducing radiation toxicity during radiotherapy for prostate cancer. A systematic review. Urology. 2021;156:e74–e85.
Miller LE, Efstathiou JA, Bhattacharyya SK, Payne JA, Woodward E, Pinkawa M. Association of the placement of a perirectal hydrogel spacer with the clinical outcomes of men receiving radiotherapy for prostate cancer: a systematic review and meta-analysis. JAMA Netw Open. 2020;3:e208221.
Pinkawa M, Corral NE, Caffaro M, et al. Application of a spacer gel to optimize three-dimensional conformal and intensity modulated radiotherapy for prostate cancer. Radiother Oncol. 2011;100:436–441.
Uhl M, van Triest B, Eble MJ, Weber DC, Herfarth K, DeWeese TL. Low rectal toxicity after dose escalated IMRT treatment of prostate cancer using an absorbable hydrogel for increasing and maintaining space between the rectum and prostate: Results of a multi-institutional phase II trial. Radiother Oncol. 2013;106:215–219.
Song DY, Herfarth KK, Uhl M, et al. A multi-institutional clinical trial of rectal dose reduction via injected polyethylene-glycol hydrogel during intensity modulated radiation therapy for prostate cancer: analysis of dosimetric outcomes. Int J Radiat Oncol Biol Phys. 2013;87:81–87.
Yonover PM, Mehta P. Hydrogel spacer use during prostate RT: Community experience. Urology Times. 2018. Available at: https://www.urologytimes.com/view/hydrogel-spacer-use-during-prostate-rt-community-experience. Accessed June 21, 2023.
What Every Urologist Needs to Know About SpaceOAR Hydrogel – How Augmenix is Improving QOL for Prostate Cancer Patients. Urology Times. May 2018. Available at: https://cdn.sanity.io/files/0vv8moc6/urologytimes/0454f8a1b348024f1e719986f833320d78618368.pdf/UT_Augmentix_supp_web.pdf. Accessed June 21, 2023.
Referenced with permission from the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines) for Prostate Cancer V.4 2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed July 18, 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.
Prostate rectal spacers. Medicare Coverage Database. CMS.gov. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx. Accessed July 25, 2023.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

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.

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

CPT Copyright © 2023 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.

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