SpaceOAR Vue™ Hydrogel

Radiopaque Perirectal Spacer for Radiation Therapy

FAQ

Clinical Outcomes

How is SpaceOAR Vue Hydrogel different than SpaceOAR™ Hydrogel?

SpaceOAR Vue Hydrogel offers enhanced visibility via CT scan, designed to help physicians improve contouring accuracy, streamline workflow by reducing the need for an MRI or an MRI-CT fusion, and may provide a suitable imaging option to MRI for men with implanted metallic devices to treat more patients.1

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.1

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

Product & Procedure

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

Like SpaceOAR Hydrogel, SpaceOAR Vue Hydrogel can also 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 is SpaceOAR Vue Hydrogel placed?

There is no difference in placement compared to SpaceOAR Hydrogel. The procedure is often done in conjunction with fiducial marker placement. SpaceOAR Vue Hydrogel is placed through the skin and sits in the perirectal fat between the prostate and the rectum and is typically administered while under some level of anesthesia.

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

SpaceOAR Vue Hydrogel can be visualized on CT imaging. If needed, the hydrogel can also be visualized on a T2 weighted MRI.1

What is SpaceOAR Vue Hydrogel made of?   

SpaceOAR Vue Hydrogel is primarily comprised of the same material as SpaceOAR Hydrogel.  The hydrogel consists mostly of water (90%) and iodinated polyethylene glycol (PEG) that when combined form a soft gel material.  PEG materials have undergone extensive biocompatible and safety testing and are used in a broad number of other implants such as surgical sealants used in the eye, brain and spine.1

Are there any contraindications with SpaceOAR Vue Hydrogel?   

SpaceOAR Vue Hydrogel does not have any contraindications.

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

Both SpaceOAR Vue Hydrogel and SpaceOAR Hydrogel are intended as a pre-treatment to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer.1  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 and SpaceOAR Hydrogel are not indicated for any other cancer at this time.

What is the shelf life of SpaceOAR Vue Hydrogel?

SpaceOAR Vue Hydrogel has a shelf life of 2 years.

What equipment do I need to use SpaceOAR Vue Hydrogel?   

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

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

Yes, SpaceOAR Vue Hydrogel is visible on kV CBCT. MV CBCT visibility is maintained as with SpaceOAR Hydrogel.1

For how long will SpaceOAR Vue Hydrogel be visible in the body?

SpaceOAR Vue Hydrogel is visible for approximately 3 months, at which point, the gel starts to break down, so the visibility diminishes over time until the hydrogel is fully absorbed at about 6 months.1

Reimbursement

Can SpaceOAR Vue Hydrogel be reimbursed?  

SpaceOAR Vue Hydrogel is currently covered by Medicare across the United States, as well as several private insurance providers. Health insurance providers may require additional information to help them understand the procedure and technology.

Effective January 1, 2018, the new Category I CPT Code for SpaceOAR Hydrogel is 55874 under descriptor: Transperineal placement of biodegradable material, peri-prostatic, single or multiple injection(s), including image guidance, when performed. 2020 SpaceOAR Hydrogel Coding and Payment Quick Reference Guide

To support healthcare providers and their facilities, Boston Scientific has a team of Field Market Access Managers and offers assistance in their efforts to educate payers and navigate through the reimbursement process.

For questions regarding SpaceOAR Vue Hydrogel:

  • General Reimbursement Information
  • Prior Authorization Assistance
  • Claims Appeal Assistance

Contact us:

Phone: (781) 332-4035

Email: SpaceOARCustReimbursement@bsci.com

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 >

*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.

1. 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 labelling 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.

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.

Health economic and reimbursement information provided by Boston Scientific Corporation is gathered from third-party sources and is subject to change 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 use of its products outside their FDA-approved label. Information included herein is current as of November 2019 but is subject to change without notice. Rates for services are effective January 1, 2020.

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. 

CPT® Disclaimer Current Procedural Terminology (CPT) Copyright 2019 American Medical Association. All rights reserved. CPT is a registered trademark of the American 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 does not 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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