Interventional and diagnostic tech company ACIST said today it enrolled the 1st patient in a study of catheter-based interrogation and standard fractional flow reserve measurement.
The study, slated to enroll 240 patients, is intended to investigate the measurement accuracy and incident of drift and device success using ACIST’s Navvus Rapid Exchange FFR microcatheter.
“As with all new technologies, it is important to understand the impact the technology can have on clinical practice and patient care. Multi-center studies like the ACIST-FFR Study are valuable as they provide data to allow us to assess technologies and their usefulness in helping to improve patient outcomes,” study investigator Dr. William Fearon of Stanford University said in a press release.
ACIST develops and produces the Navvus RXI rapid exchange FFR system, which use 0.014″ guide wires, the company said. Both FFR systems were launched in 2014.
“The introduction of the RXi Rapid Exchange FFR System in 2014, along with the recent launch of the ACIST HDi high definition IVUS System, is another step towards the transformation of the company. We built our presence by providing the first variable rate contrast injector that simplifies the delivery of contrast in the cath lab. With the addition of RXi and HDi, ACIST Medical again demonstrates its commitment to offer technologies that simplify procedures and improve patient care. The ACIST-FFR Study is our commitment to advancing science to ensure utmost safety and efficacy of our expanding product portfolio,” COO Tom Morizio said in prepared remarks.