February 15, 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 today that Wellstar Health System is among the first establishments in the nation to trial VUEWAY (gadopiclenol) injection, a recently FDA-approved macrocyclic gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI). Gadopiclenol needs only half the dose compared to other GBCAs in approved indications in the U.S. to accomplish the same image clarity due to the fact that it has the highest relaxivity of all GBCAs compared to approved GBCAs.1-7
"We are honored to stand alongside these prestigious leaders of the medical community for the first VUEWAY injections, after FDA approval," said Fulvio Renoldi Bracco, Vice-Chairman & CEO of Bracco Imaging. "We're particularly excited about our innovations in contrast imaging because of the wide-reaching impact across disease categories with 30 million MRI scans conducted annually, globally.8 That these institutions have prioritized offering VUEWAY injection, a novel next-generation MRI contrast agent, reinforces the potential value VUEWAY injection will provide in patient care and diagnostics."
VUEWAY (gadopiclenol) injection received FDA approval on Sept. 21, 2022, for use with MRI in adults and pediatric patients aged two years and older to detect and visualize lesions in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).7
Two recent Phase III trials sharing similar methodologies and endpoints demonstrate the efficacy and safety of gadopiclenol in MRI of the CNS (the PICTURE trial) and of the body (the PROMISE trial). Combining study populations, over 500 individuals had MRI scans compared when done with gadopiclenol at half the dose of a conventional agent, gadobutrol, at full dose. Even with the lower dosage, blinded readers rated gadopiclenol scans as having comparable image quality.9-11
VUEWAY injection is manufactured in the U.S. by Liebel-Flarsheim Company LLC in Raleigh, NC. 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).7
For more information: www.vueway.com
1 Robic C, Port M, Rousseaux O, et al. Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate with High T1 Relaxivity. Invest Radiol 2019; 54: 475-484.
2 GADAVIST® (gadobutrol) Injection. Full Prescribing Information. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ; April 2022.
3 DOTAREM® (gadoterate meglumine) Injection. Full Prescribing Information. Guerbet LLC. Princeton, NJ. April 2022.
4 CLARISCAN™ (gadoterate meglumine) injection for intravenous use. Full Prescribing Information. GE Healthcare. Chicago, IL; February 2020.
5 ProHance® (Gadoteridol) Injection. Full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; June 2022.
6 MultiHance® (gadobenate dimeglumine) Injection. Full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; August 2018.
7 Vueway™ (gadopiclenol) Injection Full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; September 2022.
8 Lohrke J, et al. 25 Years of Contrast-Enhanced MRI: Developments, Current Challenges and Future Perspectives. Adv Ther. 2016 Jan;33(1):1-28.
9 Loevner L, Kolumban B, Hutoczki G, et al. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System. The PICTURE Randomized Clinical Trial. Invest Radiol. 2022 Dec.
10 Clinical Study Report of Study GDX-44-010. Data on file.
11 Clinical Study Report of Study GDX-44-011. Data on file.
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