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SpaceOAR Vue™ SystemSpaceOAR Vue™ Absorbable Radiopaque Perirectal Hydrogel Spacer

Product Number: SV-2101
GTIN: 00864661000140

SpaceOAR Vue System is 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 Vue System to reduce the radiation dose delivered to the anterior rectum.


Indications, Safety, and Warnings

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Product Details

The SpaceOAR Vue System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient’s body over time.

SpaceOAR Vue Hydrogel is the next-generation polyethylene glycol (PEG)-based hydrogel spacer that offers enhanced visibility via CT scan, designed to help physicians improve contouring accuracy and consistently position patients receiving prostate cancer radiation, as compared to SpaceOAR™ Hydrogel.1

Certified applier program

We utilize a formal certification process for all new users, proctoring thousands of cases annually to ensure optimal patient outcomes. To become certified in the application of SpaceOAR Hydrogel, physicians must complete the following necessary steps.

  • Hands-on desktop demonstration of product setup & application by a certified SpaceOAR Hydrogel representative.
  • Review SpaceOAR Hydrogel System Application Physician Training Module with a certified SpaceOAR Hydrogel representative.
  • Complete multiple cases under guidance of a certified SpaceOAR Hydrogel representative, and demonstrate competency to successfully complete the SpaceOAR Hydrogel application independently.

 

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1. Data on file with Boston Scientific.

SpaceOAR Vue Hydrogel is 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 Vue Hydrogel to reduce the radiation dose delivered to the anterior rectum.

SpaceOAR Vue Hydrogel contains polyethylene glycol (PEG) and 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 Vue Hydrogel. Potential complications associated with SpaceOAR Vue Hydrogel include, but are not limited to: pain associated with SpaceOAR Vue Hydrogel injection, pain or discomfort associated with SpaceOAR Vue Hydrogel, 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-989608-AB MAR 2022

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

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