Guerbet receives FDA 510k clearance for the OptiOne™ Single-Head Contrast Delivery System

Feb 11, 2016, 08:30 ET from Guerbet

PRINCETON, N.J., Feb. 11, 2016 /PRNewswire/ -- Guerbet announced that it has received 510K clearance from the US Food and Drug Agency (FDA) for its OptiOne™ Single-Head Contrast Delivery System, featuring advanced multi-purpose  functionality for CT imaging procedures.

The US clearance confirms Guerbet's international focus in providing innovative imaging solutions to serve wider customer needs. The OptiOne is an entry-level single-head injector launched in 2015 on the European market, 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.

Guerbet will present the injector at the upcoming European Congress of Radiology (ECR, Vienna, 2-6 March 2016).

"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 innovative features technologists have come to expect from Guerbet," said Massimo Carrara, US General Manager for Guerbet LLC. "The US 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 the imaging department, 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 computed tomography equipment.

About OptiOne™ Single-Head Contrast Delivery System
The OptiOne Single-Head Contrast Delivery System is designed and intended to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used in conjunction with computed tomography equipment.  Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume, pressure and timing.  OptiOne is manufactured by Cincinnati, OH-based Liebel-Flarsheim, a company acquired by Guerbet as part of its purchase of Mallinckrodt's Contrast Media and Delivery Systems business announced on November 27, 2015.

About Guerbet

With 90 years' experience, Guerbet is a pioneer in the contrast agent field and the global specialist of the medical imaging market. It offers a comprehensive range of X-Ray, Magnetic Resonance Imaging (MRI) and Interventional Radiology and Theranostics (IRT) products, along with a range of injectors and related medical devices to improve the diagnosis and treatment of patients. The acquisition of Mallinckrodt's "contrast media and delivery systems" (CMDS) activity has doubled its size with an expanded offering. In 2014, the combined pro forma sales of Guerbet and the CMDS activity represented approximately €800 million, with around 2,500 employees. Guerbet (GBT) is listed on NYSE Euronext Paris (Segment B – Mid Caps).


SOURCE Guerbet