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Introduction to ACIST Pro™

Bracco and ACIST Medical Systems have officially launched the ACIST Pro™ Diagnostic System in Europe, marking a significant evolution in cardiovascular imaging technology. This state-of-the-art system, which is an advanced variable-rate contrast management solution, aims to enhance precision, safety, and efficiency for image-guided cardiovascular procedures. The introduction of this system is a response to the growing demands of interventional teams in the medical field, aiming to improve patient outcomes through innovation.

CE Mark and Regulatory Compliance

The ACIST Pro™ system has received the CE Mark under the European Medical Device Regulation (MDR), which indicates strict compliance with the EU’s safety, health, and environmental standards. This regulatory approval underscores the commitment of ACIST Medical Systems to deliver advanced, safe, and reliable medical technologies to healthcare professionals.

Evolution from ACIST CVi®

The ACIST Pro™ system builds upon the success of the ACIST CVi® system, which has fundamentally transformed contrast management in cardiac catheterization labs. Traditionally, manual injection methods posed significant risks, including irregularity in contrast delivery and potential harm to patients. The ACIST CVi® replaced these manual methods with automated solutions, significantly improving outcomes. Clinical studies have shown an average contrast reduction of 45ml per procedure, a 30% decrease in contrast-induced acute kidney injury (CI-AKI), and a time-saving of five minutes per case. These advancements reflect a vital progression in how contrast is managed, heralding a new standard in interventional cardiology.

Key Features and Benefits

Dr. Fulvio Renoldi Bracco, the CEO of Bracco Imaging, remarked on the importance of this launch, stating, "The ACIST Pro™ signifies a pivotal stride in our mission to advance precision imaging across various medical specialties." This sentiment encapsulates the core advantages of the new system, which include:

• - Enhanced Precision: The ACIST Pro™ system ensures accurate contrast delivery, mitigating risks associated with manual injections.
• - Improved Safety: By reducing the volume of contrast agents, the system lessens the chances of nephropathy in at-risk patients.
• - Operational Efficiency: Healthcare providers save valuable time, allowing them to focus on patient care more effectively.

Brad Fox, CEO of ACIST Medical Systems, emphasized this advanced technology's role in enhancing the clinical experience: "With its European launch, we are proud to bring this innovative solution to clinicians worldwide, reinforcing our dedication to advancing interventional imaging."

Availability and Future Prospects

The ACIST Pro™ system was initially unveiled in Japan in 2025, with expectations for a broader global rollout throughout 2026. The company is currently awaiting FDA 510(k) clearance in the United States, which will allow for the introduction of the system in American healthcare facilities. This product not only promises to improve current medical practices but also aims to usher in a new era of technological integration in cardiology.

For more information on the ACIST Pro System and other offerings from Bracco, visit acist.com/acist-pro and bracco.com.

About Bracco Group and ACIST Medical Systems

Bracco Group, established in 1927, is a leading entity in the healthcare sector, operating in over 100 countries. With an impressive portfolio of products focused on diagnostic imaging and a commitment to R&D, the company invests around 9% of its annual revenue in innovative development. ACIST Medical Systems, as part of the Bracco Group, specializes in interventional and diagnostic technology, pioneering advancements to simplify cardiovascular procedures and enhance patient care.

Stay tuned for more updates as Bracco and ACIST continue to innovate in the field of medical imaging, championing safety, precision, and performance across the European healthcare landscape.