GE HealthCare Expands Contrast Media Portfolio with Launch of MRI Agent Pixxoscan (gadobutrol)
April 27 2023 - 1:00AM
Business Wire
- The launch of Pixxoscan expands GE HealthCare’s portfolio of
Magnetic Resonance Imaging (MRI) contrast agents, now offering two
leading macrocyclic molecules to customers - Clariscan (gadoteric
acid) and Pixxoscan (gadobutrol)
- Pixxoscan has the same active substance (gadobutrol) and the
same qualitative and quantitative composition as the reference
product, Gadovist®
- The availability of Pixxoscan will give radiology departments
greater access to agents supporting a broad range of MRI
procedures, helping them in personalizing care for patients.
GE HealthCare has today announced the launch of Pixxoscan
(gadobutrol), its macrocyclic, non-ionic Magnetic Resonance Imaging
(MRI) gadolinium-based contrast agent (GBCA). Pixxoscan has been
reviewed using a regulatory decentralized procedure (DCP) with
marketing authorization already in place in Austria and pending
approval, will be introduced to a number of European countries in
2023.
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Enhanced Magnetic Resonance (MR)
procedure with cardiac scan images (Photo: Business Wire)
It has been reviewed as having the same qualitative and
quantitative composition in active substance and excipients, and
the same pharmaceutical form, as the reference product,
Gadovist.
Pixxoscan facilitates visualization of abnormal structures or
lesions and helps in the differentiation between healthy and
pathological tissue. In line with the reference product, Gadovist,
Pixxoscan (gadobutrol) is indicated for use in adults, adolescents,
and children of all ages (including term neonates) for contrast
enhancement in cranial and spinal MRI and magnetic resonance
angiography. It is also indicated for whole body imaging, including
liver and kidneys in patients with high suspicion or evidence of
having focal lesions to classify them as benign or malignant.
Gadobutrol has a high relaxivity which helps enhance detection,
delineation and characterization in MRI across its range of
indications. It is also formulated at twice the concentration of
gadolinium ions, reducing injection volume by half compared to
other GBCAs, providing a tighter bolus. Its cage-like macrocyclic
chelate, which encloses the gadolinium, provides high kinetic
stability.
Pixxoscan adds to GE HealthCare’s MRI contrast media portfolio
which includes macrocyclic Clariscan (gadoteric acid) as well as
Rapiscan, used in stress cardiac MR to aid diagnosis of coronary
artery disease and offering an alternative for patients who cannot
exercise. The availability of Pixxoscan will give radiology
departments greater access to agents supporting a broad range of
MRI procedures, helping them in personalizing care for
patients.
Dr Gianluca Pontone, Director of Perioperative Cardiology and
Cardiovascular Imaging Department, Monzino Cardiology Center,
Milan, Italy, said: “GE HealthCare continues to expand its range of
products and Pixxoscan sitting alongside cardiac stress agent,
Rapiscan, is welcome news. This gives me, as a cardiologist, the
products I need to aid in making timely diagnoses for patients with
suspected coronary artery disease.”
Mark Hibberd, Chief Medical Officer, GE HealthCare
Pharmaceutical Diagnostics, said: “This extension to our portfolio
means, we will be able to offer two leading macrocyclic molecules –
Clariscan (gadoteric acid) and Pixxoscan (gadobutrol) - to our
customers in a number of European countries, offering radiology
departments even more choice to suit their diagnostic needs. We
continue to innovate and invest in our contrast media portfolio to
deliver for healthcare professionals and patients and to meet
future demand.”
Pixxoscan (gadobutrol) offers a wide range of packaging
encompassing glass vials, ready-assembled plastic prefilled
syringes and larger volume +PLUSPAK polypropylene bottles. GE
HealthCare’s +PLUSPAK plastic packaging, using flip-top lids, helps
eliminate risk of, and downtime from, broken glass and ring-pull
injuries. +PLUSPAK also provides more choice for customers and
helps them reduce their costs and environmental impact.
As with all GE HealthCare contrast agents, Pixxoscan will be
produced in compliance with current Good Manufacturing Practices
(cGMP) - with rigorous testing at our primary and secondary
manufacturing sites in Norway to ensure high quality. Once
approved, it will then be labelled and packed for onward shipping
via our standard distribution network to local markets.
GE HealthCare’s Pharmaceutical Diagnostics unit is a global
leader in imaging agents used to support around 100 million
procedures per year globally, equivalent to three patient
procedures every second. For more than 40 years, GE HealthCare
imaging agents have been routinely used across MRI, X-ray/CT and
ultrasound to enhance clinical images and support diagnosis.
About GE HealthCare Technologies Inc. GE HealthCare is a
leading global medical technology, pharmaceutical diagnostics, and
digital solutions innovator, dedicated to providing integrated
solutions, services, and data analytics to make hospitals more
efficient, clinicians more effective, therapies more precise, and
patients healthier and happier. Serving patients and providers for
more than 100 years, GE HealthCare is advancing personalized,
connected, and compassionate care, while simplifying the patient’s
journey across the care pathway. Together our Imaging, Ultrasound,
Patient Care Solutions, and Pharmaceutical Diagnostics businesses
help improve patient care from diagnosis, to therapy, to
monitoring. We are an $18.3 billion business with 50,000 employees
working to create a world where healthcare has no limits.
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GE HealthCare Media Contact: Debbie Leven M +44 778 545
6999 Debbie.Leven@ge.com
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