Product Information for Patients

SpaceOAR™ System
Absorbable Perirectal Hydrogel Spacer
SO-1010
Introduction
SpaceOAR is a temporary implant. The implant is a soft, water-based gel (a hydrogel). It is meant to be used with
patients who will undergo prostate radiation therapy.
A trained doctor will use a needle to inject the implant between the prostate and the rectum to create space. The
space is intended to reduce the radiation delivered to the rectum, as well as bowel problems that can happen as a
result.
Your doctor will decide the best type of anesthesia to use. During your procedure, an ultrasound probe will be
placed in your rectum. The probe guides the needle placement and injection. After the injection, the needle and
probe will be removed.
Expected Lifetime of Implant
SpaceOAR maintains space for about 3 months. It is absorbed and passed naturally by the body in about 6 months.
What to Expect After the SpaceOAR Injection Procedure
After the procedure, you might feel some discomfort at the injection site. This should not last.
Check with your doctor about what to avoid after the procedure and during your radiation treatments.
Information on Safe Use
Listed below are some side effects that could happen with SpaceOAR. Ask your doctor for help to understand this
information, and to decide if this procedure is right for you.

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Indications For Use
SpaceOAR is intended to reduce the amount of radiation that is delivered to the rectum during radiotherapy for
prostate cancer. It does this by creating more space between the prostate and the rectum.
Contraindications
None known.

Precaution
• The implant contains Polyethylene Glycol (PEG). The use of this product in patients who are sensitive or allergic
to PEG has not been studied.

Side Effects That May Occur

As with any medical treatment, there are some risks involved with the use of SpaceOAR. Potential complications may
include, but are not limited to:
• Pain associated with injection
• Pain or discomfort from the hydrogel
• Site inflammation
• Infection (including abscess)

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• Inability to urinate
• Urgent need to urinate
• Constipation
• Rectal muscle spasm
• Damage to lining of rectum
• Ulcers
• Fistula (a hole between rectum and bladder, urethra, or skin below the scrotum)
• Perforation (hole in prostate, bladder, urethra, rectum)
• Necrosis (dead tissue)
• Allergic reaction (local reaction or more severe reaction, such as anaphylaxis)
• Embolism (blood vessel blockage is possible and may happen outside of the pelvis, potentially impacting vital
organs or legs)
• Fainting
• Bleeding
If one or more of these complications occur, you may need medical treatment or surgery.
If you experience any side effects, you should:
• Contact your doctor right away.
• Report any serious incident that occurs in relation to this device to Boston Scientific and to the relevant local
regulatory authority for medical devices in your country.
• For customers in Australia, report any serious incident that occurs in relation to your device to Boston Scientific
and to the Therapeutic Goods Administration (https://www.tga.gov.au).
• See the Customer Service number at the bottom of this page to contact Boston Scientific.

SpaceOAR Implant Materials

The table below lists the materials and amounts that come into contact with the patient’s body. The patient also
comes in contact with a stainless-steel needle during placement:
Material Amount
Water for Injection ~90%

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Substituted Polyethylene Glycol (PEG) <10%
Phosphate Buffer Solutions
<4%
Amine Salt
Borate Buffer Solution <1%

Magnetic Resonance (MR) Information

The SpaceOAR implant is MR Safe.

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Symbol Definitions
The following symbols are used for patient information:
Date Health care center or doctor Patient identification

Catalog Number Lot Number Serial Number

Indicates the date the device

Date of Manufacture Unique Device Identifier
must be implanted by.

MR MR Safe

SpaceOAR is a trademark of Boston Scientific Corporation or its affiliates.

All other trademarks are the property of their respective owners.

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Australian
Sponsor Address
Boston Scientific (Australia) Pty Ltd
PO Box 332
BOTANY NSW 1455 Australia
Free Phone 1800 676 133
Free Fax 1800 836 666

Boston Scientific Limited

Ballybrit Business Park
Galway IRELAND

Boston Scientific Corporation

300 Boston Scientific Way
Marlborough, MA 01752 USA
USA Customer Service +1-888-272-1001

bostonscientific.com

0344
© 2022 Boston Scientific Corporation or its affiliates.
All rights reserved.
2022-05
Your doctor’s Instructions for Use is 51455263-01A, issued 2022-01. < en >
51485445-01

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