Dr. Nicholas T. Leone of Chesapeake Urology Recognized as Center of Excellence for SpaceOAR Hydrogel

Dr. Nicholas T. Leone of Chesapeake Urology Recognized as Center of Excellence for SpaceOAR Hydrogel, a Device Designed to Reduce Unintentional Side Effects of Prostate Cancer Radiation Therapy.

Center of Excellence Recognizes a High Degree of Experience with Applying SpaceOAR Hydrogel

Pikesville, MD—January 9th, 2024—Woodholme today announced that Dr. Nicholas T. Leone of Chesapeake Urology has been designated as the first Center of Excellence in the state of Maryland 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. Nicholas T. Leone’s 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

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

“Being designated as a SpaceOAR Hydrogel Center of Excellence is an important recognition for us, and further supports our efforts to deliver the highest-quality treatment possible for prostate cancer patients in the Pikesville area,” said Dr. Nicholas T. Leone, Woodholme. “Radiation therapy is an often-successful treatment option for individuals with prostate cancer, but some patients may remain hesitant due to the unintended side effects that can impact their quality-of-life following treatment. SpaceOAR Hydrogel can complement the patient’s radiation treatment to preserve healthy tissue and help maintain quality of life.”

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**

In addition to SpaceOAR Hydrogel, Chesapeake Urology’s Woodholme location also offers SpaceOAR Vue™ Hydrogel, the nextgeneration of the device that can be seen on computerized tomography (CT) scans, negating the need for physicians to include magnetic resonance imaging (MRI) in treatment planning, and accommodating patients who are contra-indicated for MRI. SpaceOAR Vue Hydrogel is a radiopaque version of the technology designed to help physicians improve contouring accuracy and consistently position patients receiving prostate cancer radiation.

About Dr. Nicholas T. Leone

Dr. Leone practices general urology with a focus on advanced endoscopic and minimally invasive techniques for the treatment of both benign and malignant urologic diseases. He specializes in the ureteroscopic treatment of kidney stones, ureteral obstruction, and ureteral cancer, as well as laparoscopic and robotic surgery for cancer of the prostate, bladder, and kidneys.

About Chesapeake Urology

Chesapeake Urology is the largest urology practice in Maryland and the Mid-Atlantic region, providing a comprehensive array of urologic services to patients. Chesapeake Urology operates medical offices and AAAHC-certified ambulatory surgery centers in Anne Arundel, Baltimore, Harford, Howard, Carroll, Montgomery, Prince George’s, Wicomico, Worcester, MD counties, Baltimore City, and Sussex County, DE, and has a staff of more than 850, including over 90 physicians and more than 25 advanced practice providers.

For more information, visit chesuro.com or SpaceOAR.com.

* 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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Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

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