News | September 29, 2009

GE Healthcare Announces First Clinical Uses of True Integrated FFR

September 29, 2009 – GE Healthcare said the first clinical use of true integrated Fractional Flow Reserve (FFR) has been implemented at Christus St. Vincent Regional Medical Center in Santa Fe, N.M., to evaluate the severity of lesions in coronary arteries.

GE has integrated the wireless PressureWire Aeris and FFR technology from Radi Medical (now part of St. Jude Medical) into the Mac-Lab hemodynamic recording systems, eliminating the need for a separate analyzer.
This announcement comes after a report released at the 2009 European Society of Cardiology (ESC) Congress meeting (Aug. 29 through Sept. 2) in Barcelona confirmed the benefits of FFR-guided percutaneous coronary Intervention, first reported in the landmark Fractional Flow Reserve vs. Angiography in Multivessel Evaluation (FAME) Study.

The FAME study, published in the New England Journal of Medicine in January 2009, compared the 12-month outcomes of patients receiving FFR-guided treatment with treatments using angiography alone. In the study, the risk of a patient dying or having a heart attack was reduced by approximately 35 percent when FFR measurement was performed (7.3 percent for the FFR-guided group compared to 11.1 percent for the angiography-guided group). FAME also showed that the 12-month overall rate of major adverse cardiac events (MACE) was 28 percent lower for the FFR-guided group (13.2 percent for the FFR-guided group compared to 18.4 percent). This means that the likelihood of a patient having to return for further treatment (repeat stent placement or coronary artery bypass graft surgery) was significantly lower for the FFR-guided group.

In addition to the significant difference in MACE, the quality of life (freedom from angina and chest pain) for patients whose treatment was guided by FFR was equal to, and in some cases better than, that of patients whose treatment was based solely on angiography.

The follow-up data confirms that routine measurement of FFR during angioplasty can improve clinical outcomes when compared to traditional treatment after 18 months

GE Healthcare and St. Jude Medical, Inc., introduced the one of first fully integrated wireless solutions for the measurement of FFR in March 2009. Under the agreement, the FFR measurement algorithm was integrated into GE’s Mac-Lab XT and XTi hemodynamic recording systems. With FFR as just another measurement taken directly by the Mac-Lab system, it becomes part of the patient’s case record. Documenting the hemodynamic severity of lesions and combining them with other procedural data and angiographic imagery helps create a more complete patient record and promotes better clinical decisions.

FFR provides an objective value to help determine the hemodynamic severity of coronary lesions, measure the impact of a stenosis in limiting flow to the myocardium and help identify lesions responsible for ischemia. The FFR algorithm is built into the Mac-Lab recording system

“True integrated FFR on the Mac-Lab greatly simplifies the procedure with no additional equipment to set up or interface,” said Mark Zolnick, M.D., FACC, FSCAI, Christus St. Vincent Regional Medical Center. “It takes virtually no additional time to obtain this valuable parameter."

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