Medical Device Daily Associate Managing Editor
A significant population of critically ill Americans may benefit from a minimally invasive heart-monitoring device recently cleared for sale by the FDA. The new technology was designed to enable clinicians to more easily monitor patients’ conditions in a critical care setting.
The FloTrac sensor was launched in the U.S. last week by Edwards Lifesciences (Irvine, California), a well-known developer of hemodynamic monitoring technology.
The single-use sensor, which connects to a catheter that is usually already in place in many critically ill patients’ arteries, works in conjunction with the company’s new Vigileo monitor to combine data from the arterial pressure line with other patient parameters to automatically calculate cardiac output on a continuous basis.
Michael Mussallem, chairman and CEO of Edwards, told Medical Device Daily that the candidates who would need the monitoring provided by the FloTrac include “folks who are going through, for example, some sort of surgery where there would be some sort of risk associated with it.” These, he said, are patients whose vital signs one would want to watch very closely, including critical-care patients in an intensive care unit.
“What’s really the big benefit associated with FloTrac is that you can get more information in an easy-to-use format,” Mussallem said.
Until now, the company noted, patients whose conditions required monitoring beyond simple blood pressure measurements, but who were not candidates for more invasive monitoring technologies, were left with few options.
Of the estimated 13 million critically ill patients in the U.S. who receive an arterial line each year, Edwards estimates that as many as one-third could benefit from the additional hemodynamic monitoring provided by the FloTrac sensor.
“The FloTrac sensor could potentially change the standard of practice in critical care by bringing this level of monitoring to a whole new patient population,” said William McGee, MD, director of ICU quality assurance at Baystate Medical Center (Springfield, Massachusetts), in a company statement.
In critical and intensive care settings, clinicians need to monitor patients’ cardiovascular performance. Traditionally, cardiac information has been gathered through pulmonary artery catheters.
While these catheters provide the most comprehensive data on cardiac status, they are a rather invasive option for many patients.
While pulmonary artery catheters, such as Edward’s own well-known Swan-Ganz catheter, offer a wealth of valuable information, even more than the cardiac output offered by FloTrac, they require the invasive procedure of floating the catheter into the heart.
“Now you can get cardiac output, which is one of the primary things that you do get with a pulmonary artery catheter, without having to either have a clinician with the expertise necessary to load the catheter into the heart or the expertise to use it,” said Mussallem. He added that now nurses who perhaps don’t have as in-depth an understanding in using parameters from hemodynamic monitoring “have an easy-to-use device that can get them a lot of important information on their patients.”
Clinical data presented earlier this year demonstrated that the FloTrac technology has reliability comparable to the Swan-Ganz catheter. The international, multi-site study of more than 80 patients was presented by McGee at the International Symposium on Intensive Care and Emergency Medicine in Brussels, Belgium.
While the FloTrac is an important device in the company’s hemodyamic monitoring product line, Mussallem indicated that the pulmonary artery catheter would not be supplanted by the new device any time soon.
The way to think about the technology, he said is to envision a pyramid “where the most critically ill patients are at the top of the pyramid. Those people are [still] going to need much more than simple cardiac output monitoring.”
People who fit into that top category “are in severe enough shape that floating a Swan is a trivial price to pay to get that information.”
However, he said that for the large group of people who fit into the middle part of the pyramid between vital signs monitoring in the less critically ill patients and pulmonary artery catheter on the most critically ill top end, the FloTrac is an excellent choice.
“You can get a lot of information [from the FloTrac] here in an easy-to-use format and that’s why this sort of fills the gap where there’s not much there,” Mussallem said. “Sort of in between the two extremes we see as FloTrac territory.”
Anita Bessler, Edwards’ corporate vice president, global franchise management, said, “The FloTrac sensor could become one of the most important developments in critical-care monitoring since the Swan-Ganz pulmonary artery catheter, which is considered the gold standard of hemodynamic monitoring.”