October 17, 2022
MidLantic Urology’s Dean Laganosky, MD has been designated as a Center of Excellence for SpaceOAR™ Hydrogel – a device manufactured by Boston Scientific and designed to reduce the radiation dose delivered to the rectum during prostate cancer radiation treatment.
Due to the rectum’s close proximity to the prostate, it can become unintentionally damaged during therapy, leading to issues with bowel function.¹ SpaceOAR Hydrogel is designed to push the rectum away from the prostate, reducing the radiation dose delivered to the organ, which may lessen damage to the rectum.² The Center of Excellence designation recognizes Dr. Laganosky with a high degree of experience applying SpaceOAR Hydrogel* and commitment to minimizing the impact on urinary, sexual and bowel quality of life for prostate cancer patients undergoing radiation therapy.³
“To me, achieving the SpaceOAR Center of Excellence designation is a true testament to our commitment to helping our patients achieve the highest level of care during their prostate cancer treatment journey,” said Dr. Laganosky. “It signifies the high level of expertise, efficiency and safety which we provide to patients undergoing the SpaceOAR procedure, as well as the experience needed to consistently deliver excellent outcomes for our patients, including those with complex clinical presentations. It is a recognition that highlights not only my personal proficiency with SpaceOAR, but also the amazing work of our prostate cancer provider team, radiation oncologists, nurses and staff who have helped our program achieve this prestigious designation.”
Prostate cancer is the second most commonly diagnosed cancer in American men behind skin cancer, and more than 3.1 million living in the country have been diagnosed with the disease.⁴ Prostate cancer can be treated through several options, but each year, more than 60,000 patients treat their prostate cancer with radiation therapy, contributing to a nearly 100% five-year survival rate for individuals with the condition.⁴,⁵
SpaceOAR Hydrogel is made primarily of water and polyethylene glycol (PEG), a compound used in most implants, and naturally leaves the body after approximately six months.² A healthcare professional can implant SpaceOAR Hydrogel, a minimally invasive outpatient procedure, in an office, hospital, clinic or surgery center and, typically, patients can go back to normal activities soon after the procedure.⁶**
Clinical data has demonstrated the benefits of SpaceOAR Hydrogel, including a reduction in rectal injury, resulting in maintained bowel function and a higher likelihood of maintaining urinary and sexual function.⁶ SpaceOAR Hydrogel received 510(k) clearance from the FDA in 2015, and has been used in more than 150,000 procedures worldwide.⁷
* Includes SpaceOAR Hydrogel and SpaceOAR Vue Hydrogel
** Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.
- Mayo Clinic. External Beam Radiation for Prostate Cancer. Available at: https://www.mayoclinic.org/tests-procedures/external-beamradiation-for-prostate-cancer/about/pac-20384743. Accessed February 2022.
- Boston Scientific. How Does SpaceOAR Hydrogel Work? Available at: https://www.spaceoar.com/about-spaceoar-hydrogel/how-spaceoar-hydrogel-works/. Accessed February 2022.
- 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 1;97(5):976-85.
- Prostate Cancer Foundation. Treatment for Prostate Cancer: External-Beam Radiation Therapy. Available at: https://www.pcf.org/c/treatment-for-prostate-cancer-external-beam-radiation-therapy/. Accessed February 2022.
- American Cancer Society. Survival Rates for Prostate Cancer. Available at: https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html. Accessed February 2022.
- 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.
- Data on file with Boston Scientific. Number of patients is based on units shipped and a BSC proprietary algorithm.
IMPORTANT INFORMATION: These materials are intended to describe common clinical considerations and procedural steps for the use of referenced technologies but may not be appropriate for every patient or case. Decisions surrounding patient care depend on the physician’s professional judgment in consideration of all available information for the individual case.
Boston Scientific does not promote or encourage the use of its devices outside their approved labeling. Case studies are not necessarily representative of clinical outcomes in all cases as individual results may vary.
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.
SpaceOAR and SpaceOAR Vue Hydrogels contain Polyethylene Glycol (PEG). The SpaceOAR Vue Hydrogel contains 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 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; 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- 989811-AB.
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