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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. For Show Only - Do Not Copy or Forward All images are the property of Boston Scientific. All trademarks are the property of their respective owners. © 2019 Boston Scientific Corporation or its affiliates. All rights reserved. URO-666104-AA AUG 2019 A B D E C A B D E C Sterile prep tray • SpaceOAR Hydrogel • Saline • 10cc syringe Clinician Assistant Clinician Ultrasound and monitor TRUS Probe in stepper with stand-off balloon A B D E C A B D E C Sterile prep tray • SpaceOAR Hydrogel • Saline • 10cc syringe Clinician Assistant Clinician Ultrasound and monitor TRUS Probe in stepper with stand-off balloon B A B D E C Sterile prep tray • SpaceOAR Hydrogel • Saline • 10cc syringe Clinician Assistant Clinician Ultrasound and monitor TRUS Probe in stepper with stand-off balloon B A B D E C Sterile prep tray • SpaceOAR Hydrogel • Saline • 10cc syringe Clinician Assistant Clinician Ultrasound and monitor TRUS Probe in stepper with stand-off balloon B D E C A B D E C Sterile prep tray • SpaceOAR Hydrogel • Saline • 10cc syringe Clinician Assistant Clinician Ultrasound and monitor TRUS Probe in stepper with stand-off balloon B D E C A B D E C Sterile prep tray • SpaceOAR Hydrogel • Saline • 10cc syringe Clinician Assistant Clinician Ultrasound and monitor TRUS Probe in stepper with stand-off balloon median 3 years was significantly higher in the SpaceOAR Hydrogel group compared with controls (66.7% vs. 37.5%; P=.046). A recent survey of SpaceOAR Hydrogel use was performed in urology group practices. A total of 99 patients were treated in 16 centers, either in the office or in the ambulatory surgical center (ASC) setting. Procedural and patient satisfaction data were collected at the time of procedure (data on file). Analysis showed that: • 95% of cases were performed in an office setting, with the majority under local anesthesia; • The average space created between the prostate and the rectum was 10.7 mm; • 80% of investigators rated the proce- dure "very easy" or "easy," with the balance of investigators rating it "moderately easy"; • 94% of patients stated they would recommend the SpaceOAR Hydrogel procedure to others; and • 97% of patients said they were less anxious to receive radiation therapy knowing that they had SpaceOAR Hydrogel implanted and present during treatment. SpaceOAR Hydrogel is currently being used in many leading cancer centers throughout the United States. It has also received CE mark approval in Europe, is approved in Australia and Japan, and is licensed in Canada. To date, over 50,000 patients 9 worldwide have benefited from the SpaceOAR Hydrogel procedure. Figure 2. SpaceOAR Hydrogel procedure. TRUS, transrectal ultrasonography Figure 4. Anatomy with SpaceOAR Hydrogel Figure 3. SpaceOAR Hydrogel kit Figure 5. Magnetic resonance imaging illustrating SpaceOAR Hydrogel absorption Pre-implant 3-month persistence 6-month absorption Axial T2 MRI images Prostate Rectum SpaceOAR Hydrogel To learn more about SpaceOAR Hydrogel, please visit www.spaceoar.com Or, you are welcome to attend an educational SpaceOAR Hydrogel dinner on Thursday, October 17 at 6pm. Paesanos 1604 3622 Paesanos Parkway San Antonio, Texas 78231 Limited availability, please RSVP to julie.manning@bsci.com As with any medical treatment, there are some risks involved with the use of SpaceOAR Hydrogel. Potential complications associated with SpaceOAR Hydrogel include, but are not limited to: pain associated with SpaceOAR Hydrogel injection; pain or discomfort associated with SpaceOAR Hydrogel; needle penetration of the bladder, prostate, rectal wall, rectum or urethra; injection of SpaceOAR Hydrogel into the bladder, prostate, rectal wall, rectum or urethra; local inflammatory reactions; infection; injection of air, fluid or SpaceOAR Hydrogel intravascularly; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; and rectal urgency.