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</html>";s:4:"text";s:6538:"It is typically not a lengthy procedure – usually about 30 minutes. 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. You will be redirected to a map view showing you the nearest doctors to your location. All trademarks are the property of their respective owners. If you think somebody is violating your copyrights and want to notify us, you can find information The hydrogel spacer pushes the rectum away from the prostate, decreasing rectal injury during prostate radiation therapy. The brand name is the name that is typically registered with USPTO and have the ® and/or TM symbol. This number/code is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. By pushing the prostate farther from the rectum, the radiation dose delivered to the rectum is reduced, which may lessen damage to the rectum. Indicates the high value for storage and handling requirements. The device is exempt from Direct Marking requirements under 21 CFR 801.45. A SpaceOAR Hydrogel specialist will help answer your questions about SpaceOAR Hydrogel, health insurance coverage, finding a physician and more! 4. 2017 Apr 1;97(5):976-85. All images are the property of Boston Scientific. All rights reserved. Hamstra D, Shah D, Kurtzman S, et al. SpaceOAR hydrogel is an absorbable, injectable material that provides space between the rectum and prostate in men undergoing radiation therapy for prostate cancer. Brand Name: SpaceOAR System. *Please note, there may be other doctors in your area who treat prostate cancer not listed here. The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler. The date on which a device is manufactured. Indications, contraindications, warnings and instructions for use can be found in the product labeling. As with any medical treatment, there are some risks involved with the use of SpaceOAR Hydrogel. By pushing the prostate farther from the rectum, the radiation dose delivered to the rectum is reduced, which may lessen damage to the rectum. FDA Premarket submission is not required for this device. Results from case studies are not necessarily predictive of results in other cases. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. J Clin Oncol. With SpaceOAR Hydrogel in place, a doctor can complement the patient’s radiation treatment to better target their cancer while preserving healthy tissue to help maintain quality of life.1-3. 2. This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. Hamstra DA, Mariados N, Sylvester J, et al. Due to the proximity, prostate radiation therapy can unintentionally cause damage to the rectum, which can lead to issues with bowel function. Not all medical products that are NOT made with natural rubber latex will be marked. All rights reserved. Indicates the date the device is no longer held or offered for sale by the labeler on record. Numeric value for the clinically relevant size measurement of the medical device. A SpaceOAR Hydrogel specialist will help answer your questions about SpaceOAR Hydrogel, health insurance coverage, finding a physician and more! This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. Email for the Customer contact; To be used by patients and consumers for device-related questions. All rights reserved. When treating prostate cancer patients with radiation therapy, the goal is to destroy the cancer cells while avoiding damage to surrounding healthy tissue. CAUTION: The law restricts these devices to sale by or on the order of a physician. www.HIPAASpace.com privacy policies explain how we treat your personal data and protect your privacy  Device Name: The SpaceOAR System consists of components for preparation of a synthetic, absorbable hydrogel spacer and a delivery system packaged for single use. Phone Extension for the Customer  contact. The date by which the label of a device states the device must or should be used. Indicates the method(s) of sterilization that can be used for this device prior to device use on the patient. Data on file with Boston Scientific. Additional relevant information about the device that is not already captured as a distinct GUDID data attribute. SpaceOAR Hydrogel can be implanted during an outpatient procedure in a hospital, surgery center, outpatient clinic or doctor’s office prior to the start of radiation treatment. In a clinical study, SpaceOAR Hydrogel was shown to help minimize the impact on urinary, sexual and bowel quality of life for prostate cancer patients undergoing radiation therapy. Please check availability with your local sales representative or customer service. Download a discussion guide to help you talk to your doctor about whether SpaceOAR Hydrogel is right for you. 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