SpaceOAR Hydrogel has been shown to minimize the risk of bowel, urinary, and sexual side effects.2–4
Why choose SpaceOAR Hydrogel?
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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.
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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.
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2010–2012
• Augmenix SpaceOAR launches in the European Union (EU)
• One of the first publications utilizing SpaceOAR Hydrogel9
• SpaceOAR European Pilot Study9,10 -
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 – LUGPA4,11,12
• 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.
*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.
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.
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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