ACIST and Medtronic to Collaborate on Marketing RXi FFR and HDi IVUS Systems in the United States

August 4, 2014—ACIST Medical Systems, Inc., a Bracco Group company, announced that it has entered into a strategic agreement with Medtronic, Inc. to copromote the company’s rapid exchange FFR (fractional flow reserve) and high definition IVUS (intravascular ultrasound) technologies—the RXi and the HDi systems—in the United States.

Under this agreement, ACIST and Medtronic will collaborate in the marketing of these devices to cardiac catheterization labs in the United States. The ACIST RXi system was introduced earlier this year in the United States and Europe.

ACIST’s RXi system uses the company’s Navvus rapid exchange microcatheter and RXi console. The Navvus microcatheter can be used over a standard 0.014-inch guidewire, and the RXi system facilitates rapid FFR assessments before, during, and after intervention for accurate and reliable FFR measurements.

In March 2014, ACIST announced that the RXi received US Food and Drug Administration 510(k) marketing clearance for use in obtaining intravascular pressure measurements in the diagnosis and treatment of coronary and peripheral artery disease. The company has conducted clinical trials in New Zealand and Europe. The first successful human case featuring the new system in the United States took place in Minnesota in February 2014.

Antonio Colombo, MD, of the Centro Cuore Columbus in Milan, Italy, has conducted live case demonstrations with the technology at the TCT.13, JIM, and CRT 2014 interventional cardiology conferences. In the March announcement, Dr. Colombo commented, “The ACIST RXi rapid exchange FFR System is one of the most exciting developments in interventional cardiology in the last 5 years. By allowing the use of standard guidewires to deliver the fiber-optic–driven pressure sensor, the RXi may simplify FFR measurement, allowing it to be used routinely for detection of ischemia-related lesions when objective evidence of vessel-related ischemia is not available.”