Illustration of SpaceOAR Hydrogel

A little space makes a BIG difference

SpaceOAR™ Hydrogel



What is SpaceOAR Hydrogel?

SpaceOAR Hydrogel is designed to temporarily create space between the prostate and rectum, and reduce the radiation dose delivered to the rectum during radiation therapy. It has been clinically shown to help minimize urinary, sexual and bowel side effects and help protect the quality of life for prostate cancer patients undergoing radiation therapy.1-3



  • 2011
    • One of the first publications utilizing SpaceOAR Hydrogel4
  • 2015
    • Randomized control trial published3
    • SpaceOAR Hydrogel launches in us
  • 2017
    • 3-year clinical trial results published1
  • 2018
    • Category 1 CPT code granted5
    • Boston Scientific acquires SpaceOAR Hydrogel
  • 2020
    • Purchased at 19 of the top 20 cancer centers in US5
    • Recommended as a pre-treatment option within the NCCN Clinical Practice Guidelines in Oncology6
    • Nationwide Medicare coverage achieved5
    • Next-generation SpaceOAR Vue Hydrogel (enhanced visibility on CT) launches in US
  • 2021
    • SpaceOAR Vue Hydrogel launches in the EU
    • Referenced in numerous peer-reviewed clinical publications
    • 150,000 SpaceOAR Hydrogel patients to date and growing*

*Number of patients is based on units shipped and a BSC proprietary algorithm


 

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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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SpaceOAR Hydrogel has been shown to help minimize the risk of bowel, urinary and sexual side effects.1-3

bowel side effects

FEWER BOWEL COMPLICATIONS

Shown reduction in bowel quality of life declines by 70% at median 3 years1

urinary side effects

FEWER URINARY COMPLICATIONS

Shown to reduce the likelihood of urinary quality of life decline by more than 60% at 3 years1

sexual side effects

FEWER SEXUAL COMPLICATIONS

SpaceOAR Hydrogel patients who had erections sufficient for intercourse at baseline were 67% more likely to retain sexual function at 3 years2







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Doctor talking to patient

What Radiation Oncologist and Urologists 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

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


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


SpaceOAR Vue Hydrogel

Next-generation perirectal spacer - visibly different

Partnership & solutions

Patient reimbursement and more





Boston Scientific is committed to reducing health inequities among underserved populations. Our mission is to close health inequity gaps for women and people of color through improving health inequity awareness, empowering healthcare providers and increasing clinical representation.




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. 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 Sep;100(3):436-41.
  5. Data on file with Boston Scientific.
  6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Guideline Name V.2.2020. © National Comprehensive   Cancer Network, Inc. 2020. All rights reserved. Accessed July 8, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org.
  7. National Cancer Institute. SEER Cancer Statistics Review 1975-2006. https://seer.cancer.gov/archive/csr/1975_2006/. Accessed June 8, 2021.
  8. Gilligan T, Wang PS, Levin R, Kantoff PW, Avorn J. Racial Differences in Screening for Prostate Cancer in the Elderly. Arch Intern Med. 2004;164(17):1858–1864.     doi:10.1001/archinte.164.17.1858.
  9. Iyengar S, Hall IJ, Sabatino, SA. Racial/ethnic disparities in prostate cancer incidence, distant stage diagnosis, and mortality by U.S. census region and age-group, 2012-2015. Cancer Epidemiol Biomarkers Prev. 2020 Jul;29(7):1357-64.
  10. Lichtensztajn D, Leppert JY, Brooks JD, et al. Under-treatment of high-risk localized prostate cancer in the California Latino population. J Natl Compr Canc Netw.  2018 Nov;16(11):1353-60.
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 labeling supplied with each device. Information for use only in countries with applicable health authority registrations. This material not intended for use in France.
Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please check availability with your local sales representative or customer service.
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.
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; needle penetration of the bladder, prostate, rectal wall, rectum or urethra; injection of SpaceOAR and SpaceOAR Vue Hydrogels into the bladder, prostate, rectal wall, rectum or urethra; local inflammatory reactions; infection; injection of air, fluid or SpaceOAR and SpaceOAR Vue Hydrogels intravascularly; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; and rectal urgency. URO-989811-AA
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