April 2, 2014 — 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 technology is the first of its kind, providing the reassurance of accurate and reliable FFR measurements and the advantages of rapid exchange platform.
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.
RXi received 510(k) Food and Drug Administration (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 five 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."
For more information: www.acist.com