ACIST Launches RXi Rapid Exchange FFR System

March 29, 2014—ACIST Medical Systems, Inc., (Eden Prairie, MN), a Bracco Group company, announced the global introduction of the ACIST RXi rapid exchange fractional flow reserve (FFR) system at ACC.14: the 63rd annual scientific session of the American College of Cardiology being held March 29–31 in Washington, DC. The technology is designed to provide accurate and reliable FFR measurements with the advantages of rapid exchange technology.

According to ACIST, the RXi 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 control while maintaining wire position throughout the coronary procedure. The RXi system also facilitates rapid FFR assessments before, during, and after interventions, to quickly assess blockages that could require percutaneous coronary intervention (PCI).

The system uses fiber-optic technology for 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 compared to wire-based FFR systems, noted ACIST.

ACIST advised that in January 2014, the RXi system received 510(k) clearance from the US Food and Drug Administration for use in obtaining intravascular pressure measurements in the diagnosis and treatment of coronary and peripheral artery disease. The company successfully conducted a clinical trial in New Zealand and is currently performing an additional study in Europe. The first successful human case using the new system in the United States was conducted in Minnesota in February 2014.

“The ACIST RXi rapid exchange FFR system is one of the most exciting developments in interventional cardiology in the last 5 years,” commented Antonio Colombo, MD, in company’s press release. Dr. Colombo, who is from the Centro Cuore Columbus in Milan, Italy, has conducted live case demonstrations at TCT.13, JIM, and CRT 2014 interventional cardiology conferences.  He continued, “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.”