St. Jude Medical and GE Healthcare Announce Worldwide Market Launch of Wireless Integrated FFR Solution

St. Jude Medical, Inc. and GE Healthcare today announced the worldwide commercial launch of the first fully integrated wireless solution for the measurement of Fractional Flow Reserve (FFR). 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 acquired in December 2008 by St. Jude Medical and is now part of the Company’s Cardiovascular Division.

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 Augusto Pichard, M.D., professor of medicine, Cardiology, and director of cardiac cath labs, Washington Hospital Center, Washington, D.C. “The integration with our existing GE hemodynamic recording system means that traditional limitations of FFR measurements, including utilizing a stand alone machine for calculation, are removed.”

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 Sweden. “FFR is a highly valuable clinical tool for the interventional cardiologist, guiding the PCI procedure for improved patient outcomes and lowered cost. The combination of our innovative wireless PressureWire Aeris and the Mac-Lab FFR upgrade makes this tool readily available in a large number of cathlabs worldwide.

Source:  St. Jude Medical

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