GE Healthcare Announces New Compatibility for Fractional Flow Reserve Evaluation with the Mac-Lab Hemodynamic Recording Systems

GE Healthcare, the $17 billion medical technology division of General Electric Company, today announced the expansion of Mac-Lab’s validation of compatibility to the Volcano’s SmartMap Pressure Instrument and PrimeWire Pressure Guide Wire for evaluation of Fractional Flow Reserve (FFR).

To date, coronary angiography is the standard method for guiding the placement of a stent in patients with multivessel coronary artery disease who are undergoing percutaneous coronary intervention (PCI). However, the landmark FAME2 (Fractional Flow Reserve vs. Angiography in Multivessel Evaluation) study reported the benefits of the evaluation of FFR, a physiological measure of coronary stenosis, in addition to angiography, to improve outcomes of PCIs.

The FAME study demonstrated that the risk of a patient dying or suffering a heart attack was reduced by approximately 35 percent when FFR measurement was performed. The study also showed that the 12-month overall rate of Major Adverse Cardiac Events (MACE) was 28% lower for the FFR guided group, reducing significantly the likelihood of a patient having to return for further treatment (repeat stent placement or coronary artery bypass graft surgery).

These findings were validated in new guidelines released by the American Cardiology College (ACC), American Heart Association (AHA) and the Society for Cardiac Angiography and Interventions (SCAI). In the guidelines, the level of evidence for the use of FFR was raised to “A” (highest level), stating that FFR “can be useful to determine whether PCI of a specific coronary lesion is warranted.”3

“GE Healthcare is committed to helping physicians determine accurate, safe diagnoses for the benefit of their patients,” says Hooman Hakami, President and CEO, Interventional Systems at GE Healthcare. “In line with our healthymagination imperatives, we were the first to provide true integration of FFR with our Mac-Lab system. With this latest release, we are pleased to expand the capability of our Mac-Lab system to support both the St. Jude Pressurewire Aeris Wireless and the Volcano’s SmartMap Pressure instrument. By giving our customers more flexibility in patient care, we help enable the interventional cardiologist to improve long term patient outcomes and lower procedural cost.”

Following the announcement of the first true FFR integration in cooperation with RADI/St. Jude Medical at TCT 2008, the Mac-Lab system is expanding its scope and now supports both the St. Jude Pressurewire Aeris Wireless and the Volcano’s SmartMap Pressure instrument.

With this release GE Healthcare is forthwith providing customers with additional options in using FFR to guide Percutaneous Coronary Interventions at the same ease of use physicians accustom from the Mac-Lab recording system.

1 American Heart Association

2 Fractional Flow Reserve versus Angiography for Guiding Percutaneous Coronary Intervention” Pim A.L. Tonino, M.D, et al writing for the FAME study investigators, N Engl J Med 360:213, January 15, 2009

3 2009 Focused updates: ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2009;120:2271–2306.

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