CT Exprès^® 3D Contrast Media Delivery System

CT Exprès^® 3D Contrast Media Delivery System
INDICATIONS:
The CT Exprès^® 3D Contrast Media Delivery System is indicated for controlled automatic administration, on the venous side, of contrast media and saline, to human subjects while undergoing examination by means of a computed tomography (CT) scanner.

The CT Exprès 3D Contrast Media Delivery System is specifically indicated for use in CT procedures for the delivery of ISOVUE (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of 20 bottles of contrast media or a maximum of ten (10) hours, whichever comes first, per Day Set III HP disposable. The Bottle Spike disposable is for single-bottle use only and must be discarded with the contrast media bottle. The Patient Set must be discarded after each patient procedure.

The CT Exprès 3D is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.

CONTRAINDICATIONS:
This device is not intended for injection of contrast media for coronary arteriography, or for any other use for which the device is not indicated.

Bracco Injeneering S.A. reserves the right at any time and without notice, to change the specifications and features described herein, or to change the production or adjust the product described.

Not all products are available in all global markets.

CT Exprès is distributed by Bracco Diagnostics Inc., 259 Prospect Plains Road, Bldg. H, Monroe Township, NJ 08831 USA; Phone: (800) 631-5245; Fax: (609) 514-2424; Customer Service: 1-877-BRACCO 9 (1-877-272-2269)); CT Exprès Email: empowerinfo@diag.bracco.com.

CT Exprès is manufactured for Bracco Injeneering S.A., Avenue de Sévelin 46, CH-1004 Lausanne, Switzerland. https://imaging.bracco.com

About Bracco Injeneering S.A.
Bracco Injeneering S.A., located in Lausanne, Switzerland, is the most recently added Business Unit of Bracco Imaging. Bracco Injeneering is committed to develop the best-in-class integrated injection solutions with a strong heritage in research and innovation. It provides quality solutions for state-of-the-art radiology centers, offering proven injection technology, built on Bracco Imaging’s expertise.

Thanks to this strengthened product portfolio, including the CT Exprès 3D Contrast Media Delivery System, EmpowerCTA^®+ Injector System, EmpowerMR^® Injector System, NEXO^® Contrast Management System and NEXO [DOSE]^® Multi-Modality Radiation Informatics, Bracco Imaging will be able to focus on constant innovation, not only for devices, but also for software development and data management.

CT Exprès, EmpowerCTA, EmpowerMR, NEXO and NEXO [DOSE]^® are registered trademarks of Bracco Injeneering S.A.

Indications and Usage for ISOVUE^®-300 (Iopamidol Injection 61%) Imaging Bulk Package and
ISOVUE^®-370 (Iopamidol Injection 76%) Imaging Bulk Package
ISOVUE^® (Iopamidol Injection) Imaging Bulk Package (IBP) is indicated for angiography throughout the cardiovascular system in adults, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, selective visceral arteriography and aortography, peripheral venography (phlebography), and in pediatric patients for angiocardiography; or for intravenous contrast enhancement of computed tomographic (CECT) imaging of the head and body in adult and pediatric patients.

The ISOVUE (Iopamidol Injection) Imaging Bulk Package is for use with an automated contrast injector or a contrast management system approved or cleared for use with it.

IMPORTANT SAFETY INFORMATION:
Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events.

As with all injectable contrast agents, the possibility of severe reactions should be borne in mind, regardless of the patient’s pre-existing medical history. As with any other iodinated contrast media, caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered. Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration.

Please see full Prescribing Information for ISOVUE Imaging Bulk Package by clicking here.

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.

ISOVUE and ISOVUE-M are currently manufactured for Bracco Diagnostics Inc. at three locations: BIPSO GmbH, Singen (Germany), Patheon Italia S.p.A., Ferentino (Italy) and S. M. Farmeceutici SRL, Tito (Italy).

ISOVUE and ISOVUE-M are registered trademarks of Bracco Diagnostics Inc.