|St. Jude Medical and GE Healthcare Announce Worldwide Market Launch of Wireless Integrated FFR Solution|
The new FFR solution, seamlessly integrated into existing cathlab infrastructure, will enable physicians and cathlab staff immediate access to FFR measurement without time consuming setup.
The solution is based on the PressureWire® Aeris technology and an FFR
upgrade package available for the XT and XTi system configurations of
GE’s Mac-Lab® hemodynamic recording system, a system used to record and
display physiological parameters in the coronary cathlab. PressureWire
Aeris was developed and marketed by Radi Medical Systems, which was
The Mac-Lab FFR upgrade utilizes existing cathlab infrastructure, including screens, input modules and controls, and together with the PressureWire Aeris technology forms a seamlessly integrated FFR measurement system for greatly improved cathlab workflow and ease of use.
“The PressureWire Aeris system represents a true paradigm shift in our
thinking about the accessibility of FFR,” said
With all FFR results integrated into the existing physiological information archive, this new solution is also the only system on the market where the hemodynamic severity of coronary lesions, as measured by FFR, is documented together with other procedural data and angiographic imagery, creating a more complete patient record.
"Combining the strength of GE's Mac-Lab hemodynamic recording system with the performance of PressureWire Aeris in the assessment of FFR has the potential to enhance clinical workflow tremendously," said Omar Ishrak, president and chief executive officer of GE Healthcare Systems. "We are pleased to offer a tool which enables the interventional cardiologist to guide coronary procedures with higher accuracy, improving long term patient outcomes and lower procedural cost."
The Mac-Lab FFR solution is available as an upgrade path to all existing GE Mac-Lab installations worldwide, as well as new installations.
"The incorporation of FFR and PressureWire Aeris into GE Mac-Lab is a
major advancement as we work to make FFR standard of care in the
interventional cathlab. With FFR available directly in the existing
hemodynamic recording system the need for additional equipment is
removed and the procedure setup is reduced to the flip of a switch,"
said Anders Qvarnström, vice president and general manager of the St.
Jude Medical Cardiovascular Division in
About Fractional Flow Reserve (FFR)
Fractional Flow Reserve (FFR) is an index determining the functional severity of narrowings in the coronary vasculature and it is measured by PressureWire Aeris. FFR specifically identifies which individual coronary narrowing is responsible for significantly obstructing the flow of blood to a patients heart muscle (called ischemia) and it is used by the interventional cardiologist to direct coronary interventions and assess results for improved treatment outcomes.
The landmark trial FAME (Fractional flow reserve (FFR) vs. Angiography
in Multivessel Evaluation), published in the
The FAME study, in which pressure guidewires from Radi Medical Systems were exclusively used, also showed that FFR measurement is cost-saving and does not add time to the procedure.
About Radi Medical Systems
Radi Medical Systems develops, manufactures and sells medical devices
designed to improve patient care. The company’s pioneering work in the
field of interventional cardiology has resulted in market-leading
intravascular sensors and hemostasis management devices. The company was
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