ACIST Launches The RXi Rapid Exchange FFR System

March 31, 2014

Allows quick and easy assessment of FFR values with Ultra-Thin Navvus™ MicroCatheter that can be used over standard 0.014 inch guidewires

EDEN PRAIRIE, MN ---- ACIST Medical Systems, Inc. announced at the American College of Cardiology's 63rd Annual Scientific Session in Washington, D.C. the global introduction of the new ACIST|RXi Rapid Exchange FFR System – the world's first Rapid Exchange FFR system. This device features new technology designed to provide physicians with a fast and easy way to perform Fractional Flow Reserve (FFR) procedures.

The new Rapid FFR system utilizes the ultra-thin ACIST Navvus™ Rapid Exchange MicroCatheter and RXi console. The Navvus MicroCatheter can be used over a standard 0.014 inch guidewire, providing the physician maximum control while maintaining wire position throughout the coronary procedure. The RXi system also facilitates rapid FFR assessments before, during and post-intervention, to quickly assess blockages that could require Percutaneous Coronary Intervention (PCI).This unique technology is the first of its kind, providing the reassurance of accurate and reliable FFR measurements and the advantages of Rapid Exchange technology.

"The introduction of the RXi Rapid Exchange FFR System, the first system of its kind in the world, is a major step forward in the transformation of ACIST," said Tom Morizio, President and COO, ACIST Medical Systems. "We built our presence by providing the first variable rate contrast injector that simplifies the delivery of contrast in the Cath Lab. The introduction of the Rapid FFR technology again demonstrates our commitment to providing innovations to the interventionalist. The technology in the RXi Rapid Exchange FFR System overcomes many of the limitations of traditional pressure-wire systems. It is highly accurate and easy to use. This device will continue to evolve and advance our mission to simplify the complexities in the Cath Lab."

FFR is a fast-growing market within interventional cardiology. With the stent market facing scrutiny about placement and usage, FFR procedures are growing in popularity worldwide. To meet this growing demand, ACIST has created technology that takes a unique approach from the existing wire-based technologies. In addition to being a Rapid Exchange catheter, the ACIST Rapid FFR system utilizes fiber-optic technology, resulting in greater signal stability and less potential for signal drift. The ultra-thin Navvus MicroCatheter features simple plug and play by not requiring calibration therefore saving time and increasing ease of use versus older FFR wire-base systems.

"The RXi rapid exchange system for measuring FFR is a significant technology advancement that will extend the use of FFR and allow physicians to better identify which patients will benefit from coronary stenting. The increased use of FFR measurements will improve patient outcomes," said Dr. Robert Wilson, founder of ACIST Medical Systems.

RXi received 510(k) FDA clearance for use in obtaining intravascular pressure measurements in the diagnosis and treatment of coronary and peripheral artery disease in January 2014. The company successfully conducted a clinical trial in New Zealand and is currently performing an additional study in Europe. The first successful human case featuring the new system in the United States took place in Minnesota in February 2014. The new technology continues to draw praise from participating physicians citing the new device's simple and intuitive approach.

"The ACIST|RXi™ Rapid Exchange FFR System is one of the most exciting developments in interventional cardiology in the last 5 years," said Dr. Antonio Colombo of the Centro Cuore Columbus, Milan, Italy, who has conducted live case demonstrations at TCT.13, JIM, and CRT 2014 interventional cardiology conferences. "By allowing the use of standard guidewires to deliver the fiber-optic driven pressure sensor, the RXi may simplify FFR measurement allowing it to be used routinely for detection of ischemia-related lesions when objective evidence of vessel-related ischemia is not available."

"The technology of the new RXi Rapid Exchange FFR System sets new standards in emerging cardiology solutions and strengthens ACIST's position as a global market leader," said Fulvio Renoldi Bracco, chairman of ACIST and head of the Global Business Unit Imaging of Bracco Group, the parent company of ACIST and HLT. "In both companies we continue to develop innovation with our products, following paths that deliver game-changing solutions that better enable physician performance and lead to positive patient results."

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