About Bracco and CT Colonography (CTC) & Bracco Imaging

 

Bracco and CT Colonography (CTC):

The National Colorectal Cancer Roundtable (NCCRT), established by the American Cancer Society (ACS) and the Centers for Disease Control and Prevention (CDC), recently developed a campaign to increase Colorectal Cancer screening rates: “80% screening by 2018.” At Bracco we believe that by offering eligible patients the option of a visual, non-invasive, patient-friendly screening method such as CTC, the NCCRT’s goal of increasing adherence to CRC can be met, perhaps even exceeded.

To assist healthcare professionals in performing CTC, Bracco provides 2 important products: the PROTOCO2L TOUCH® Colon Insufflator and TAGITOLTM V (Barium Sulfate Suspension 40% w/v, 30% w/w) Stool Tagging Agent, which have been developed to meet the needs of modern radiology practices.

 

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is one of the world’s leading companies in the diagnostic imaging business. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions that meet medical needs.

Bracco Imaging offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray Imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers. The diagnostic imaging portfolio is completed by a range of medical devices and advanced administration systems for contrast imaging products.

The company operates in over 100 markets worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. With on-going research covering all key modalities, Bracco Imaging has a strong presence in key geographies: North America, Europe and Japan operating through the Joint Venture Bracco-Eisai Co. Ltd. The company also operates in Brazil, South Korea, and China through the Joint Venture Bracco Sine Pharmaceutical Corp. Ltd.

Operational investments have been made in order to achieve top quality, compliant and sustainable eco-friendly production. Manufacturing activities are located in Italy, Switzerland, Japan, China, and Germany.

Bracco Imaging is an innovative Research and Development (R&D) structure with an efficient process oriented approach and a track record of innovation in the diagnostic imaging industry. R&D activities are managed in the three Research Centers located in Italy, Switzerland, and the USA.

To learn more about Bracco Imaging, visit http://www.braccoimaging.com/us-en.

Bracco Product Information

PROTOCO2L TOUCH® Colon Insufflator

Indications and Usage:
The PROTOCO2L TOUCH Colon Insufflator administers and regulates carbon dioxide as a distention media to the colon during CTC or Virtual Colonoscopy.

The PROTOCO2L TOUCH Colon Insufflator provides a software controlled insufflation of carbon dioxide during CT Colonoscopy (CTC). Carbon dioxide is more rapidly absorbed than room air and helps minimize the patient’s post-procedure bloating and cramping. The PROTOCO2L TOUCH Colon Insufflator helps reduce staff time during the colon insufflation process and enhances productivity. Automated insufflation helps ensure adequate and consistent distension in a patient- and operator-independent manner. It also features a specially designed small tip for patient comfort, as well as safety features to help protect against over-insufflation.

IMPORTANT SAFETY INFORMATION:
The PROTOCO2L TOUCH Colon Insufflator should be used only when colon insufflation is indicated, and should therefore not be used for any other treatment. It should only be used under the direct guidance of a physician experienced in colon insufflation.

PROTOCO2L TOUCH Instructions for Use may be obtained by contacting Bracco Diagnostics Professional Services Department at 800-257-5181, Option 2.

PROTOCO2L TOUCH is manufactured for Bracco Diagnostics Inc., Monroe Twp., NJ 08831.

PROTOCO2L TOUCH is a registered trademark of E-Z-EM, Inc.

TAGITOLTM V (Barium Sulfate Suspension 40% w/v, 30% w/w) Stool Tagging Agent

Indications and Usage:
For use in opacifying residual stool in the colon during CTC. TAGITOL V (Barium Sulfate Suspension 40% w/v, 30% w/w) Stool Tagging Agent is a low-volume radiopaque marker that blends into stool as it forms. With just a 20mL dose with breakfast, lunch and dinner the day prior to the exam, TAGITOL V Stool Tagging Agent provides immediate, visible identification of retained feces via comparative density analysis, simplifying the distinction between tagged feces and colonic abnormality.

IMPORTANT SAFETY INFORMATION:
This product should not be used in patients with known or suspected gastric and intestinal perforation, or hypersensitivity to barium sulfate or any component of this barium sulfate formulation. Rarely, severe and occasionally fatal allergic reactions have been reported following administration of barium sulfate contrast agents.

Please see full Prescribing Information for TAGITOL V Stool Tagging Agent at http://www.braccoimaging.com/us-en/products/ct-ct-colonography/tagitol-v

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

TAGITOL V is manufactured by E-Z-EM Canada Inc., for E-Z-EM, Inc., a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 08831.

TAGITOL is a trademark of E-Z-EM, Inc.