PRINCETON, N.J., Dec. 3, 2020 /PRNewswire/ -- Guerbet (GBT), a global leader in medical imaging, announced today that it received US Food and Drug Administration approval for the commercial sale of the Optiray® Imaging Bulk Package (IBP) in the United States, as well as FDA clearance of the LF IBP Transfer Set.

Guerbet's Optiray IBP has the capability to fill sterile single-use syringes when used with a power injector and a cleared contrast media transfer set, Guerbet's Optiray IBP presentation is an efficient option because it can reduce the number of single dose vials opened without requiring preparation in a laminar flow hood or pharmacy facility.

The Optiray IBP will be available in 500mL bottles in 2021 for the Optiray 320 and Optiray 350 concentrations
"Guerbet's new Optiray IBP offers our customers the flexibility they seek in the CT suite, with a labeled maximum use time of 12 hours once pierced – presently the longest among iodinated contrast IBPs available in the US. Our innovative product portfolio continues to provide efficient solutions for healthcare providers and their patients," said Thomas McLaughlin, VP, Guerbet North America.

Customers with questions are encouraged to contact Guerbet's Customer Service Department via phone at (877) 729-6679, or via email at customer.service-us@guerbet.com

Important Safety Information1

WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTATION

FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY.

Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

INDICATIONS AND USAGE
Intra-arterial use in adults:

Optiray 300: cerebral arteriography, and peripheral arteriography
Optiray 320: cerebral arteriography, peripheral arteriography, visceral and renal arteriography, aortography, coronary arteriography, and left ventriculography
Optiray 350: peripheral arteriography, coronary arteriography, and left ventriculography
Intra-arterial use in pediatric patients

Optiray 320 and Optiray 350: angiocardiography
Intra-venous use in adults

Optiray 300: CT imaging of the head and body, venography, and intravenous excretory urography
Optiray 320: CT imaging of the head and body, venography, and intravenous excretory urography
Optiray 350: CT imaging of the head and body, venography, intravenous excretory urography, and intravenous digital subtraction angiography (IV-DSA)

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