Edwards previews new minimally invasive heart monitor at SCCM

17 January 2005

Edwards Lifesciences Corporation (NYSE: EW), a global leader in haemodynamic monitoring technologies, is previewing its Edwards FloTrac sensor, a new minimally invasive haemodynamic monitoring device, at the Society of Critical Care Medicine's (SCCM) 34th Critical Care Congress, January 15—19 in Phoenix, Arizona, USA

Clinicians monitor patients' cardiovascular performance with a variety of haemodynamic monitoring tools, depending upon a patient's condition. In critical and intensive care settings, clinicians need to monitor cardiac output, including oxygen saturation levels, blood pressure and blood volume, preferably on a continuous basis. Traditionally, these critical parameters have been gathered through pulmonary artery catheters that are threaded into a patient's heart. Edwards, which pioneered pulmonary artery catheter technologies and is the world's leading haemodynamic monitoring company, developed the FloTrac sensor so clinicians could gauge some of these patient parameters less invasively.

The Edwards FloTrac sensor provides certain key continuous cardiac
measurements by accessing data directly from an arterial line, which is a small catheter inserted into the patient's radial artery. Most critically ill or surgical patients in hospitals already have an arterial line in place to measure basic cardiovascular information and to draw blood, making the FloTrac sensor very easy to use.

The sensor's unique technological platform enables clinicians to elect a
less-invasive option for those patients who need hemodynamic monitoring, but who may not require all of the parameters offered by Edwards' line of Swan-Ganz catheters.

"Edwards' Swan-Ganz catheter is considered the 'gold standard' for
conventional hemodynamic monitoring," said Anita B. Bessler, Edwards corporate vice president, global franchise management. "We developed the FloTrac technology to enable clinicians to assess hemodynamic parameters for a broader population of patients who could benefit from monitoring but who traditionally are not candidates for the more invasive existing technology.

"Initial clinician feedback from FloTrac sensor pilot studies has been
very positive," Bessler added, "and we expect to make this product widely available in the US and Europe later this year, pending the appropriate regulatory approvals."

Gerard R Manecke, Jr, MD, clinical professor in UC San Diego School of Medicine's department of anesthesiology, reported at the SCCM on January 16 that a preliminary study of 11 heart surgery patients demonstrated that the FloTrac sensor provided a reliable, minimally invasive method for measuring cardiac output, when compared with the Swan-Ganz catheter.

Edwards Highlights Latest Critical Care Monitoring Technologies
In addition to previewing its FloTrac sensor at the SCCM 2005 Congress, Edwards also is launching its new Vigilance II monitor, the next generation of continuous cardiac output and oximetry monitors for use with Swan-Ganz catheters. The Vigilance II monitor features a streamlined design, as well as a large, color, customizable display. The Vigilance II monitor also offers clinicians a unique data graph, which can simplify complex data and provide a clearer picture of hemodynamic performance, thereby allowing clinicians to more easily assess a patient's condition.

Edwards' PreSep central venous oximetry catheter, which serves as an
integral part of Early Goal-Directed Therapy for managing sepsis, also will be highlighted in several scientific sessions at SCCM. Edwards is featuring its PreSep catheter, along with the FloTrac sensor and the Vigilance II monitor, at booth #2601 in the Phoenix Civic Plaza exhibit hall at SCCM.

Edwards also is hosting an educational program, "The Hemodynamic
Monitoring Landscape: Broader Horizons," for SCCM attendees on January 18 at the Phoenix Civic Plaza. Featured speakers will include Michael R. Pinsky, MD, professor of critical care management at the University of Pittsburgh; Vincente H. Gracias, MD, medical director of surgical critical care at the University of Pennsylvania Hospital; and William T. McGee, MD, assistant professor of critical care medicine at Tufts University School of Medicine in Boston, Mass.

Additional company information on Edwards Life Sciences can be found at


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