Guerbet Receives FDA Clearance for OptiOne System

Guerbet LLC has received U.S. Food and Drug Administration 510(k) clearance for its OptiOne Single-Head Contrast Delivery System, featuring advanced multi-purpose functionality for computed tomography (CT) imaging procedures.

The OptiOne is an entry-level single-head injected launched in 2015 in Europe, available in ceiling-suspended and pedestal form. It is designed for the injection of radiopaque contrast agents in the vascular system of patients to obtain diagnostic images in CT scan examinations. Guebert will present the injector at the upcoming European Congress of Radiology conference in Vienna, Austria, March 2-6.

“We are extremely pleased to announce the availability of this newest injector system, as we believe that it offers additional flexibility to our customers, while providing the features technologists have come to expect from Guerbet,” said Massimo Carrara, U.S. general manager for Guerbet. “The U.S. approval for OptiOne builds upon Guerbet’s commitment to be a global leader specializing in contrast media and imaging solutions and services.”

The OptiOne Single-Head Contrast Delivery System combines ease-of-use, multi-purpose functionality and optimized contrast media usage. It is designed to be adaptable to the workflow of imaging departments, providing a fully programmable powerhead with intuitive bedside operation and flexibility of use with the ability to accommodate prefilled or empty syringes.

The OptiOne is intended for use by doctors, radiology technologists and other licensed medical practitioners in a healthcare facility or hospital with CT equipment. Each injection of radiopaque contrast media is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume, pressure, and timing. OptiOne is manufactured by Cincinnati, Ohio-based Liebel-Flarsheim, a company acquired by Guerbet as part of its purchase of Mallinckrodt’s Contrast Media and Delivery Systems business last fall.

Guerbet is a French developer and provider of contrast agents, offering a range of X-ray, magnetic resonance imaging and interventional radiology and theranostics products along with injectors and related medical devices to improve the diagnosis and treatment patients.