ACIST Medical Systems announced at the American College of Cardiology’s 63rd Annual Scientific Session in Washington, DC the global introduction of the new ACIST RXi rapid exchange fractional flow reserve system – the world’s first rapid exchange fractional flow reserve system. This device features new technology designed to provide physicians with a fast and easy way to perform fractional flow reserve procedures.
The new rapid fractional flow reserve system utilises the ultra-thin ACIST Navvus rapid exchange micro-catheter and RXi console. The Navvus micro-catheter 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 fractional flow reserve assessments before, during and post-intervention, to quickly assess blockages that could require percutaneous coronary intervention. This unique technology is the first of its kind, providing the reassurance of accurate and reliable fractional flow reserve measurements and the advantages of rapid exchange technology.
According to ACIST, in addition to being a rapid exchange catheter, the ACIST rapid fractional flow reserve system utilises fibre-optic technology, resulting in greater signal stability and less potential for signal drift. The ultra-thin Navvus micro-catheter features simple plug and play by not requiring calibration therefore saving time and increasing ease of use versus older fractional flow reserve wire-base systems.
“The RXi rapid exchange system for measuring fractional flow reserve is a significant technology advancement that will extend the use of fractional flow reserve and allow physicians to better identify which patients will benefit from coronary stenting. The increased use of fractional flow reserve measurements will improve patient outcomes,” says Robert Wilson, founder of ACIST Medical Systems.
RXi received 510(k) US 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 ACIST RXi rapid exchange fractional flow reserve system is one of the most exciting developments in interventional cardiology in the last five years,” says 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 fibre-optic driven pressure sensor, the RXi may simplify fractional flow reserve measurement allowing it to be used routinely for detection of ischaemia-related lesions when objective evidence of vessel-related ischaemia is not available.”