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Frequently Asked Questions on SpaceOAR Hydrogel

Review common questions and answers on SpaceOAR Hydrogel. If you're not finding an answer to your question, please contact our team for additional assistance.

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Clinical outcomes

 

 

How can SpaceOAR Hydrogel Systems help patients undergoing radiation therapy for prostate cancer?

SpaceOAR Hydrogel Systems are absorbable hydrogel spacers clinically shown to help minimize the impact on urinary, sexual and bowel quality of life for patients undergoing radiation therapy.1-3

How do SpaceOAR Hydrogel Systems work?

SpaceOAR Hydrogel Systems are FDA cleared and intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer. In creating this space, it is the intent of SpaceOAR Hydrogel Systems to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Hydrogel Systems are composed of a biodegradable material and maintain space for the prostate radiotherapy treatment and are absorbed by the patient’s body in approximately 6 months.

Perirectal spacers have also been recommended as a pre-treatment option within the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).*

Are the clinical benefits of SpaceOAR Hydrogel found in SpaceOAR Vue Hydrogel?

SpaceOAR Vue Hydrogel is the next-generation hydrogel that is designed to offer similar clinical benefits that SpaceOAR Hydrogel provides.4





Product and procedure

 

 

How is SpaceOAR Vue Hydrogel different than SpaceOAR Hydrogel?

SpaceOAR Vue Hydrogel contains PEGylated Iodine which offers enhanced visibility via CT scan. The radiopacity is designed to help physicians improve contouring accuracy, streamline workflow by reducing the need for a second MRI or an MRI-CT fusion, and may provide a suitable imaging option to MRI for patients with implanted metallic devices.

SpaceOAR Vue Hydrogel may be used in patients with iodine sensitivity when carefully considered on a case-by-case basis.

What is the hydrogel made of?

Both SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel consist mostly of water (90%) and polyethylene glycol (PEG) that, when combined, form a soft gel material. PEG materials in general have undergone extensive biocompatibility and safety testing and are used in a broad number of other implants such as surgical sealants for the eye, cranium and spine.

Are there any contraindications with SpaceOAR Hydrogel Systems?

SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel do not have any contraindications.

Where is the procedure done and how long does it take?

SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel can be implanted as an outpatient procedure in a hospital, surgery center, outpatient clinic or doctor’s office prior to the start of radiation treatment. It is typically not a lengthy process.

How are SpaceOAR Hydrogel Systems placed?

The procedure is often done in conjunction with fiducial marker placement. SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel are placed through the skin of the perineum using an 18-gauge needle and sit in the perirectal fat between the prostate and the rectum.

For how long will SpaceOAR Hydrogel Systems stay in the body?

SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel stay in place for approximately 3 months, at which point the gel starts to break down, until the hydrogel is absorbed at about 6 months.4

How do I see the gel post application for treatment planning purposes?

SpaceOAR Vue Hydrogel is a next-generation hydrogel spacer that offers enhanced visibility on a CT scan. SpaceOAR Hydrogel can be visualized on a T2 weighted MRI.4

Can I see SpaceOAR Vue Hydrogel on cone-beam CT (CBCT)?

Yes, persistent visibility of SpaceOAR Vue on a kV cone-beam CT is designed to aid in visualization of the target region enabling appropriate patient positioning for radiation treatment.

Can the SpaceOAR Hydrogel Systems be used with any other types of cancer?

Both SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel are intended as a pre-treatment to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer.4 In creating this space, it is the intent of SpaceOAR Hydrogel Systems to reduce the radiation dose delivered to the anterior rectum. SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel are not indicated for any other cancer at this time.

What is the shelf life of SpaceOAR Hydrogel Systems?

SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel have a shelf life of 2 years.

What equipment do I need to place SpaceOAR Hydrogel Systems?

A stepper/stabilizer stand and an ultrasound equipped with a real-time bi-plane transrectal probe are required for SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel procedures.1





Reimbursement

 

 

Can SpaceOAR Hydrogel Systems be reimbursed?

Yes, the procedure for placing SpaceOAR Hydrogel products is currently covered by Medicare across the United States, as well as by several private insurance providers. Health insurance providers may require additional information to help them understand the procedure and technology. Payment varies by geographic locale.

Download the medicare fact sheet >

Download the private payer fact sheet >

Download the hospital outpatient fact sheet >

Boston Scientific also offers a dedicated SpaceOAR Hydrogel reimbursement hotline to support your patients with benefit verification, pre-authorization submissions, follow-up with payer, and assistance with benefit questions as well as appealing support for on-label uses, when necessary. For additional questions, email: SpaceOARCustReimbursement@bsci.com

Learn more >

What CPT Code is used to bill for SpaceOAR Hydrogel Systems?

All payers require Category I CPT Code 55874 for SpaceOAR Hydrogel under descriptor: Transperineal placement of biodegradable material, peri-prostatic, single or multiple injection(s), including image guidance, when performed.

Download the 2022 SpaceOAR Hydrogel Coding & Payment quick reference guide

Do you offer grants/financial assistance to study SpaceOAR Vue Hydrogel?

Boston Scientific proudly supports independent medical research, education programs and charitable projects that further medical and scientific knowledge by offering funding and resources to U.S. based healthcare institutions, academic medical centers, medical societies and national associations.

Learn more >

 
 
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*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.

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. Data on file with Boston Scientific.
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
Health economic and reimbursement information provided by Boston Scientific Corporation is gathered from third-party sources and is subject tochange 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 useof 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. The coding options listed within this guide are commonly used codes and are not intended to be an all-inclusive list. We recommend consulting your relevant manuals for appropriate coding options. This coding information may include codes forprocedures for which Boston Scientific currently offers no cleared or approved products. In those instances, such codes have been included solelyin the interest of providing users with comprehensive coding information and are not intended to promote the use of any Boston Scientific productsfor which they are not cleared or approved. The Health Care Provider (HCP) is solely responsible for selecting the site of service and treatment modalities appropriate for the patient based on medically appropriate needs of that patient and the independent medical judgement of the HCP
Current Procedural Terminology (CPT) Copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of theAmerican 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 doesnot directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
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