Questions on clinical outcomes
SpaceOAR Hydrogel Systems are absorbable PEG-based hydrogel spacers clinically shown to help minimize the impact on urinary, sexual and bowel quality of life for patients undergoing radiation therapy.1-3
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®).*
SpaceOAR Vue Hydrogel is the next-generation hydrogel that is designed to offer similar clinical benefits that SpaceOAR Hydrogel provides.4
Questions on product and procedure
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.
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.
SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel do not have any contraindications.
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.
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.
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
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
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.
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.
SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel have a shelf life of 2 years.
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
Questions on reimbursement
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.
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
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.
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