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ACIST Medical Systems Announces Approval and Launch of Next-Generation FFR System

ACIST RXi® MiniTM System Seamlessly Integrates with Cath Lab Hemodynamic System and FFR Software

DENVER and EDEN PRAIRIE, MINN. (October 27, 2017) — ACIST Medical Systems, Inc., a Bracco Group Company, today announced the global launch of its ACIST RXi® MiniTM System, the next generation system of its RXi Rapid Exchange FFR System. The RXi Mini System will debut at the 29th Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Denver, Colorado.

The RXi Mini is designed to provide fractional flow reserve (FFR) measurements to complement angiography, provide qualitative assessment of lesion severity, and inform intervention strategy in both diagnosis and treatment of coronary and peripheral artery disease. The system is designed to seamlessly integrate with existing hemodynamic systems and FFR software. The RXi Mini offers flexible mounting configurations, a simple and intuitive user interface, and a small and unobtrusive system profile that adapts to your existing workflow and maximizes procedural efficiency.

The first case in the United States and the world was performed by Dr. Michael Lim, MD and Director of Cardiology at St. Louis University in St. Louis, Missouri. During a complex case performed by Dr. Lim, the RXi Mini System was utilized to measure FFR multiple times during the procedure. Dr. Lim noted “ACIST has raised the bar in making physiology accessible and easy to use in the cath lab setting.” The small RXi Mini system is about the size of a fist and connects into hospital hemodynamic systems where the measurements can be taken and recorded by lab staff, making the procedure go more smoothly and quickly. “FFR is the gold standard in diagnosing which lesions will most likely benefit from coronary interventions, including stent placement. The ACIST Rapid FFR Mini RXi system makes it much simpler to perform FFR, whenever it is called for. With this advance, it continues to become easier to guide treatment decisions by invasive physiologic measurement – there really aren’t that many excuses left for the interventionalist to skip this step!”

Unlike standard pressure wires, the ACIST RXi Mini System and Navvus® Rapid Exchange FFR MicroCatheter, allows physicians to use their 0.014” guide wire of choice throughout the procedure, addressing challenges of pressure wires, including accessibility in challenging anatomies, maintaining wire position, pressure‐measurement drift and ease of obtaining post‐intervention FFR.

“ACIST is excited about the additional value and flexibility that the RXi Mini will provide the cath lab,” said Brad Fox, President and CEO, ACIST Medical Systems, Inc. “This next generation FFR solution reflects our continued organizational commitment to providing technologies that simplify procedures and help physicians improve patient care.”

About ACIST

ACIST Medical Systems, Inc. is a pioneering interventional and diagnostic technology company with a portfolio of advanced products, including the world’s first Rapid Exchange FFR and High Definition IVUS systems. It is also a global market leader in advanced contrast imaging systems for cardiovascular angiography and radiology imaging. Through these products, ACIST is demonstrating its commitment to bringing unique and innovative technologies that simplify cardiovascular procedures and empower clinicians to treat patients with superior care. As part of the Bracco Group, ACIST benefits from the resources of a multinational conglomerate with broad expertise in cath lab technology and a dedication to continuous advancement. Headquartered in Eden Prairie, Minnesota, USA, ACIST has worldwide presence with over 300 direct employees and facilities in Silicon Valley, Heerlen, and Tokyo. To learn more about ACIST, visit www.acist.com.

Bracco Group

Bracco has headquarters in Milan, Italy, and was founded in 1927. It is active in the healthcare sector through Bracco Imaging (diagnostic imaging), ACIST Medical Systems and HLT (cardiology) and the Centro Diagnostico Italiano diagnostic clinic. It has around 3,400 employees and annual total consolidated revenues of over 1.3 billion Euro. Bracco operates in more than 100 countries worldwide. To learn more about Bracco Group, visit www.bracco.com

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