American College of Radiology Classifies VUEWAY as a Group II Agent Relative to NSF

May 16, 2023 — Bracco Imaging, an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio inclusive of precision diagnostic imaging modalities, announced that the American College of Radiology (ACR) has classified VUEWAY (gadopiclenol) as a Group II agent within its classification of gadolinium-based contrast agents relative to the risk of development of nephrogenic systemic fibrosis (NSF).²

The ACR Committee on Drugs and Contrast Media states that, "Gadopiclenol demonstrates kinetic stability and a long dissociation half-life that is comparable to other Group II macrocyclic agents," and therefore considers that, "the risk of NSF among patients exposed to standard or lower than standard doses of gadopiclenol is sufficiently low or possibly nonexistent such that it has been classified as a Group II agent."² 

"We are pleased that the ACR Committee on Drugs and Contrast Media classified gadopiclenol as a Group II agent, in view of its very high stability, and made healthcare professionals aware of the low risk of NSF with this agent," said Alberto Spinazzi, MD, Chief Medical and Regulatory Officer at Bracco. "We are encouraged by the steady stream of medical institutions who have added VUEWAY injection to their formulary in view of the high stability and high relaxivity of this agent, and the benefit it provides to patients. We look forward to its continued adoption across the U.S. and globally, as we work towards regulatory approvals in other countries."

VUEWAY injection is approved for use in adult and pediatric patients aged 2 years and older with magnetic resonance imaging (MRI) of the CNS (brain, spine, and surrounding tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) at the dose of 0.05 mmol/kg.¹

For more information: www.vueway.com

References:

Related content:

VIDEO: Talking Trends with Bracco: Investing in the Future of Radiology

Bracco and Guerbet Partner to Expand Access to Novel Imaging Agent

First Nationwide Use of Bracco's VUEWAY (gadopiclenol) Solution for Injection for MRI

Guerbet Announces Commercial Launch and First Patient Dosing of Elucirem (Gadopiclenol) Injection

Related Content of MRI Gadolinium Safety Concerns 

The Debate Over Gadolinium MRI Contrast Toxicity 

VIDEO: How Serious is MRI Gadolinium Retention in the Brain and Body? An interview with Max Wintermark, M.D. 

VIDEO “Big Concerns Remain for MRI Gadolinium Contrast Safety at RSNA 2017,” An interview with Emanuel Kanal, M.D. 

Radiology Has Failed to Properly Assess or Track MRI Gadolinium Contrast Safety 

Recent Developments in Contrast Media 

FDA Committee Votes to Expand Warning Labels on Gadolinium-Based Contrast Agents 

European Medicines Agency Issues Update on Gadolinium Contrast Agents 

ISMRM Issues Guidelines for MRI Gadolinium Contrast Agents 

FDA: No Harm in MRI Gadolinium Retention in the Brain 

VIDEO: MRI Gadolinium Contrast Retention in the Brain 

Gadolinium May Remain in Brain After Contrast MRI