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

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[junkie-alert style=”grey”] ACIST Medical Systems, Inc., a Bracco Group Company, today announced the global launch of its ACIST RXi® Mini™ 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. [/junkie-alert]

The design of the RXi Mini:  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.

Acist reports that 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.”