Acist Medical Begins Enrollment in FFR Study

November 16, 2015—Acist Medical Systems, Inc. announced the beginning of enrollment in the company-sponsored FFR Study, an assessment of catheter-based interrogation and standard techniques for fractional flow reserve (FFR) measurement. The study will evaluate measurement accuracy, incidence of drift, and device success in 240 patients at 12 sites in the United States.

In 2014, the company launched the Acist RXi rapid exchange FFR system and the Navvus rapid exchange FFR microcatheter. The FFR Study data results, along with the ACCESS-NZ Trial results (used for both US Food and Drug Administration clearance and European CE Mark approval), will seek to further demonstrate the clinical utility of the Navvus FFR device in everyday practice.

The FFR Study’s coprincipal investigators are Matthew Price, MD, of Scripps Clinic in La Jolla, California, and William Fearon, MD, of Stanford Hospital in Palo Alto, California. Dr. Fearon, who is Professor of Cardiovascular Medicine at Stanford University, enrolled the first patient in the trial on November 14.

In the company’s press release, Dr. Fearon commented, “As with all new technologies, it is important to understand the impact the technology can have on clinical practice and patient care. Multicenter 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.”