Acist touts consistent, correlative performance of Navvus Microcath in FFR study
ACIST Medical Systems yesterday released the results from its Acist-FFR study examining the use of catheter-based interrogation and standard techniques for fractional flow reserve measurement, touting consistent and correlative performance with its Navvus MicroCatheter.
The 245-patient multi-center study examined patients with stable coronary artery disease and assessed the differences in FFR values obtained using the Navvus MicroCatheter versus a standard pressure wire.
Findings indicated that the microcatheter produced consistently and modestly lower FFR measurements compared to a pressure wire, with an average difference of -0.022 in 97% of the cases. Differences measured did not impact clinical decision making, the company said.
“As the use of FFR in clinical practice continues to grow, it becomes increasingly important to understand the benefits and limitations of each type of FFR technology in regards to delivering consistent measurements and making coronary intervention procedures as efficient as possible,” Acist-FFR co-principal investigator Dr. William Fearon of the Stanford University School of Medicine said in a prepared statement.
Data indicated that while the mean pressure drift was not different between the microcath and the pressure wire, the rate of clinically significant pressure drift was numerically higher with the pressure wire, at 3.5% versus 7.4% respectively.
“The difference found between FFR measurements with a pressure wire and microcatheter tended to be influenced by RVD and lesion length; however, from a practical perspective, the clinician can just look at the microcatheter FFR itself. The lower the Navvus FFR, the greater the bias. Since the bias is less at FFR values within the gray zone and higher, on average the clinical impact of the difference will be minimal. This study confirms and expands upon previous findings in a much more robust manner. It is encouraging to see these data further validate the diagnostic capabilities and technical merit of microcatheter FFR technology,” Acist-FFR co-principal investigator Dr. Matthew Price of the Scripps Clinic said in a prepared release.
“We are excited that the results of this direct comparison study add to the growing body of evidence supporting microcatheter FFR technology. This robust study and its findings reflect our commitment to proving out the technologies that simplify procedures and help physicians improve patient care,” prez & CEO Tom Morizio said in a press release.