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New fractional flow reserve system enters global market
ACIST Medical Systems has announced the global introduction of its RXi rapid exchange fractional flow reserve system, a first-of-its-kind technology, according to a press release.
The device utilizes the ultrathin ACIST Navvus rapid exchange microcatheter and RXi console. The microcatheter can be used over a standard 0.014-inch guidewire, and the RXi system facilitates rapid FFR assessments before, during and after the intervention, according to the release. The ACIST rapid FFR system uses fiber optic technology for enhanced signal stability and less potential for signal drift, whereas the microcatheter features a simple plug and play that does not require calibration, ACIST Medical Systems stated.
In January, the RXi system received 501(k) FDA clearance for use in obtaining intravascular pressure measurements for the diagnosis and treatment of coronary and peripheral arterial disease.
To date, ACIST Medical Systems has successfully completed a study in New Zealand, is performing an additional study in Europe and completed its first successful human case with the system in the United States in February.
Perspective
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The RXi system is compact, user friendly and allows me to utilize any guidewire within the coronary artery that I choose without losing wire position across the coronary lesions and stenoses I am assessing. Also, the rapid exchange Navvus microcatheter can be placed across the lesion using my wire of choice and FFR can be measured. If the lesion produces a significant FFR number and I elect to revascularize that region with angioplasty and stenting, the wire utilized to support that procedure remains an option for me to use in the procedure.
In general, this new system broadens the range of utilization of FFR to assess lesions when they are angiographically in question, and helps to clarify whether they are flow-limiting stenoses that could potentially cause angio-like symptoms — there is a wide variety and significant number of angiographic stenoses that fall under this category. The RXi system allows an operator to more easily assess them, and do the right thing for the patient.
The other part that is significantly different in this system is that the pressure is transmitted via a fiber optic signal. That is different than the signal transduction in the currently available pressure wires. If you are going to measure FFR across a stenosis in question, you want the most accurate data possible that are reflective of what that lesion is really causing instead of things such as drift or artifacts in the pressure signal. The ACIST system produces accurate results with less signal drift.