Bracco’s MRI Innovations: Introducing the Max 3™ Syringeless Injector System
As an industry leader in radiology, Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., is committed to pushing the boundaries of innovation to meet the evolving needs in diagnostic imaging. Bracco’s approach is rooted in listening to and collaborating with customers, leading to solutions that address real-world challenges and enhance radiology’s impact on patient care. With this legacy of forward-thinking technologies, Bracco remains at the forefront of radiology, empowering clinicians to drive patient care with cutting-edge solutions in diagnostic imaging.
Today, the company is expanding its portfolio of leading MRI products with the Max 3™, a Rapid Exchange and Syringeless Injector System for use in MRI procedures. The Max 3 was developed through a
long-term partnership between Bracco Imaging and ulrich GmbH Co. KG, a renowned German medical device manufacturer specializing in contrast media injectors and spinal implants. This strategic collaboration brings Max 3 to the United States under an exclusive private label arrangement.
The recent FDA 510(k) clearance makes the Max 3 the first of its kind in the MRI space, empowering intuitive, efficient workflow and supporting best practices in sustainability and hygiene. Bracco introduced Max 3 at the 2024 Radiological Society of North America (RSNA) Scientific Assembly and Annual Meeting. With the production of the Max 3, Bracco recently announced they are ready to share this innovation with the MRI market.
Efficient and Effective Contrast Management
The Max 3 injector offers direct injection from original contrast media vials, eliminating the need to fill syringes. It allows for quick and easy operation to accommodate fast and simple patient changeover.
“It’s a change for the market now. It’s an innovation that will evolve into the future, driving efficiency, operations, and sustainability,” said Pete Nardell, associate director of device and informatics marketing.
The Max 3 injector is wireless with no power cables, so it can be positioned anywhere in the MRI room up to a maximum magnetic field strength of 50mT. The Easy-Click-Cassette flex has a dedicated connector to the patient tubing with SafeConnect, providing contact protection and reliable protection against retrograde contamination which can be used within 24 hours or up to a maximum of 96 bottles of contrast media, whichever comes first. This feature helps improve workflow for the technologist and gives them more time to focus on the patient during a procedure.
“The great thing about the Max 3 is that it‘s easy to use and can be moved around the suite. It‘s not only syringeless, but it‘s wireless too. There are easy, simple instructions for the techs, and it allows for easy and quick patient changeover,” said Amy Black, marketing manager for devices and informatics.
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The Max 3 injector’s innovative design earned it a Red Dot Design Award, an international competition recognizing product design, communication design, and design concepts. The new MR injector’s advanced design and capabilities leave customers thoroughly impressed and excited to try it in their MRI suites.
“The reaction has been incredible. We’re taking a very methodical approach to the market, meeting with thought leaders and implementing their perspectives into our strategies. That’s made the Max 3 an injector for all health systems, including clinical, research and academic settings,” said Nardell.
Enhancing Safety and Sustainability
In addition to being easy to use, the Max 3 injector offers advanced safety features like an air monitoring system and particle filtration system. “I'm really excited about that because patient safety is paramount. It's also a closed system, so the hygiene is absolutely top-notch,” said Black.
The Max 3 also aligns with best practices in radiology sustainability. Nardell said this injector will strengthen green efforts in radiology suites because it will contribute less plastic to a hospital's disposable processes and costs. “One of our core principles includes sustainability, which we’ve incorporated throughout our contrast management systems and our devices,” he explained.
Black said Bracco’s commitment to caring for the patient, the medical ecosystem, and the future of the planet aligns with industry initiatives to reduce environmental impact. “There's so much excitement about the syringeless Max 3 and how it supports sustainability. We’re thrilled to partner with our customers on that initiative,” said Black.
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An MR Innovation Organization
The Max 3 represents Bracco’s dedication to continuous innovation, education programs, environmental sustainability, and building trust with customers and the entire radiology community.
At the heart of the company’s innovation lies a shared commitment to collaboration and purpose-driven progress. Nardell believes Bracco and clinicians can jointly accelerate the delivery of impactful solutions that empower healthcare providers to enhance patient outcomes and shape a bright future for radiology.
“We’re not just a device organization; we’re an innovation organization across modalities, and the Max 3 is a prime example of MRI innovation. Through that, we offer educational opportunities and product portfolios, including MRI injectors, AI solutions, and contrast agents. If you look at our total solution portfolio, we offer MRI innovation across the board, and we continue to build upon that education with innovative products and our portfolio to support the entire radiology community,” said Nardell.
ulricheasyINJECT Max 3™ (the Bracco-branded Max 3™, a Rapid Exchange and Syringeless MR Injector System) is distributed by Bracco Diagnostics Inc
Indications for use
ulricheasyINJECT Max 3 is a contrast media (CM) management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.
ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of VUEWAY® (gadopiclenol) solution for injection &emdash; Bracco Diagnostics Inc., MultiHance® (gadobenate dimeglumine) injection – Bracco Diagnostics Inc., Clariscan™ (gadoterate meglumine) injection – GE Healthcare Inc., DOTAREM® (gadoterate meglumine) Injection – Guerbet, LLC, Gadavist® (gadobutrol) injection – Bayer HealthCare Pharmaceuticals Inc., and Gadobutrol Injection – Fresenius Kabi AG, contrast media as supplied in approved single dose vials and Gadavist (gadobutrol) Injection – Bayer HealthCare Pharmaceuticals Inc. and Gadobutrol Injection – Fresenius Kabi AG, contrast media as supplied in approved Imaging Bulk Packages (IBPs).
The ulricheasyINJECT Max 3 is not intended for injection of contrast media for high-pressure angiography.
Easy-Click-Cassette – flex Max 3 is used for a maximum time of twenty-four (24) hours or a maximum of 96 bottles of contrast media, whichever comes first.
Use time expiration per single dose contrast media container is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling.
Use time expiration per IBP contrast media container is a maximum of twenty-four (24) hours per contrast media container, unless otherwise stated by the contrast media labeling.
Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.
ulricheasyINJECT Max 3 (XD 10180) is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.
Contraindications
ulricheasyINJECT Max 3 injectors are not intended for the administration of contrast medium during high-pressure angiography or other applications that do not comply with the intended use.
The injector is not protected against the effects of defibrillation. Before a defibrillator is used, the patient must be disconnected from the ulricheasyINJECT Max 3 injector.
Do not add any disposables (i.e. connector tubing or valves) to the ulricheasyINJECT Max 3 with the patient tubing that are not provided by ulrich medical. No valves or other connectors may be placed
in-line between the patient tubing and the patient cannula. The disposables identified in this IFU are designed, manufactured, and tested for connection with cannulas for pressure injections.
Do not use ulricheasyINJECT Max 3 injectors with any other contrast media (other than those described in the IFU). Any other contrast media are inappropriate and should not be used. Do not operate the injector and terminal, including any accessories, in potentially explosive atmospheres or in the vicinity of combustible materials (especially anesthetic drugs, detergents, and oxygen-enriched environments).
ulricheasyINJECT Max 3 is manufactured by ulrich GmbH & Co. KG.
ulrich medical is a registered trademark of ulrich GmbH & Co. KG.
ulricheasyINJECT Max 3 is a trademark of ulrich GmbH & Co. KG.
ulricheasyINJECT Max 3 is distributed as the Bracco-branded Max 3, a Rapid Exchange and Syringeless MR Injector System, by Bracco Diagnostics Inc.; 510 Carnegie Center, Suite 300, Princeton, NJ 08540 USA; Phone: (800) 631-5245; Fax: (609) 514-2424; Customer Service: 1-877-BRACCO 9 (1-877-272-2269); Scientific Information: 1-800-257-5181 (Option 2); Website: https://smartinject.com/max3/
All other trademarks and registered trademarks are the property of their respective owners.
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