ACIST Launches The RXi™ Rapid Exchange FFR System

-- 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, Minnesota, March 29, 2014 /PRNewswire/ -- ACIST Medical Systems, Inc., a Bracco Group company, pioneer and global market leader of advanced contrast delivery systems for cardiology, today 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.  

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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."

About FFR
FFR measurement is a technique used in cardiology to determine the effect of narrowing, or stenosis, in the coronary arteries on blood flow. It allows for a more effective assessment of coronary lesions then when only using angiography, the gold-standard imaging technique. By identifying which stenoses are causing ischemia by significantly restricting the blood flow to the heart muscle and causing the patient's symptoms, FFR can help avoid unnecessary stenting to reopen the blood vessels, leading to improved patient outcomes.^{1, 2}

About ACIST
ACIST, a Bracco Group company, is a pioneer and global market leader of advanced contrast delivery systems for cardiology. By developing advanced diagnostic technologies that help simplify the complexities of the cardiac cath lab, it empowers clinicians and their teams in providing superior patient care. ACIST products are being used by cardiologists in more than 70 countries worldwide, and more than 15 million patients have benefited from a cardiovascular angiography procedure using an ACIST Contrast Delivery System.

ACIST is headquartered in Eden Prairie, Minn., with regional offices in Europe and Asia. A team of more than 300 people worldwide helps manage and support a portfolio of products and services that simplify and enhance contrast injection procedures. ACIST and its sister company, HLT — a medical device company dedicated to the development of transcatheter aortic valve technology — are part of the Bracco Group, an international leader in diagnostic imaging. Both companies share the same founder, president and COO and commitment to innovation in interventional cardiology. Together, they are setting new standards in the industry with the pursuit of emerging cardiology solutions, addressing clinical and physician needs to provide superior patient care.

To learn more about ACIST, visit www.acist.com.

About the 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), Pharma (prescription and over the counter drugs), ACIST Medical Systems and HLT (cardiology) and the Centro Diagnostico Italiano diagnostic clinic. It has around 3,300 employees and annual total consolidated revenues of over 1.2 billion Euro. Bracco operates in more than 90 countries worldwide.

To learn more about Bracco Group, visit www.bracco.com.

1. Tonino PA et al. New Engl J Med 2009;360:213-24
2. De Bruyne B et al. New Engl J Med 2012;367:991-1001