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SpaceOAR™ Hydrogel

Clinical Data

SpaceOAR Hydrogel evidence summary

Creating more space between the prostate and rectum can result in a significant reduction in rectal radiation.¹ The reduction in rectal radiation can help reduce late rectal toxicity, which may help maintain quality of life.²

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+1 cm

ON AVERAGE,

+1 cm space3

73%

LESS

Rectal radiation1

75%

LESS

 Late grade 1 rectal toxicity2

Person with a heart icon.

Better Quality of Life1,2

As compared to the control group within this specific study

Systematic review & meta-analysis

SpaceOAR Hydrogel is associated with lower rectal toxicity and higher bowel quality of life in long-term follow-up⁴

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SpaceOAR Hydrogel has been shown to minimize side effects2,5

0%

Late grade 2+ rectal toxicity2

70%

Less decline in bowel quality of life2

60%

Reduced likelihood of decline in urinary quality of life5

67%

Retained sexual function3

Real-world data shows how different treatment approaches can utilize SpaceOAR Hydrogel

A Pooled Long-Term Follow-up After Radiotherapy for Prostate​ Cancer with and without a Rectal Hydrogel Spacer: Impact of​ Hydrogel on Decline in Sexual Quality of Life​

Seymour ZA, Pinkawa M, et al.

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Early Tolerance and Tumor Control Outcomes with High-Dose Ultrahypofractionated Radiation Therapy for Prostate Cancer

Zelefsky MJ, Pinitpatcharalert A, Kollmeier M, et al.

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Dosimetric Feasibility of Neurovascular Bundle-Sparing Stereotactic Body Radiotherapy with Periprostatic Hydrogel Spacer for Localized Prostate Cancer to Preserve Erectile Function

Hwang ME, Mayeda M, Shaish H, et al.

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Expanding the Utilization of Rectal Spacer Hydrogel for Larger Prostate Glands (>80cc): Feasibility and Dosimetric Outcomes

Fagundes M, Rodrigues MA, Olszewski S, et al.

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Rectal Hydrogel Spacer Improves Late Gastrointestinal Toxicity Compared to Rectal Balloon Immobilization After Proton Beam Radiotherapy for Localized Prostate Cancer: A Retrospective Observational Study

Dinh TT, Lee HJ, Macomber MW, et al.

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SpaceOAR Vue™ Hydrogel: The Next-Generation Radiopaque Hydrogel Spacer

Brenneman RJ, Baumann BC

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SpaceOAR Hydrogel Spacer Injection Prior to Stereotactic Body Radiation Therapy for Men with Localized Prostate Cancer

Payne HA, Pinkawa M, Peedell C, et al.

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Hydrogel Spacer Distribution Within the Perirectal Space in Patients Undergoing Radiotherapy for Prostate Cancer: Impact of Spacer Symmetry on Rectal Dose Reduction and the Clinical Consequences of Hydrogel Infiltration into the Rectal Wall

Fischer-Valuck BW, Chundury A, Gay H, et al.

View clinical summary

SABRE Trial

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SpaceOAR System Indications, Safety, and Warnings
SpaceOAR Vue Indications, Safety, and Warnings

References

  1. 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.
  2. 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.
  3. Data on file with Boston Scientific. 
  4. 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.
  5. 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. 

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.

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