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Edwards Lands CE Mark for Hypotension Detector
Nancy Crotti
October 4, 2016
2 Min Read
.svg?width=850&auto=webp&quality=95&format=jpg&disable=upscale "Edwards Lands CE Mark for Hypotension Detector")
The software automatically updates advanced parameters every 20 seconds to better reflect rapid physical changes in moderate to high-risk surgical or critical care patients.
Nancy Crotti
Edwards Lifesciences has scored the CE Mark for a new software program designed to alert clinicians to potential abnormally low blood pressure in surgical or critical care patients, according to a company statement.
The Acumen Hypotension Probability Indicator (HPI) is only compatible with Edwards's technology. It runs off the Edwards's HPI-activated EV1000 monitor, which receives information from ithe company's minimally invasive FloTrac IQ sensor. The software comprises three elements:
The hypotension probability parameter, which indicates the possibility of a hypotensive event using machine-learning techniques developed from more than 20,000 past patient events;
An alarm that alerts clinicians when hypotension probability exceeds an upper threshold;
And a secondary screen that visually links blood pressure to hemodynamic flow parameters, such as cardiac output and contractility.
This is the latest piece of good news for Edwards, which had the third best stock performance among the world's 88 largest medical device companies during the first nine months of 2016, up nearly 53% in value to more than $120 per share on the New York Stock Exchange.
The FloTrac IQ sensor that the software works with connects to any existing arterial catheter to provide physicians with information to determine a patient's fluid status. It automatically updates advanced parameters every 20 seconds to reflect rapid physical changes in moderate to high-risk surgery more accurately.
As software designed for the hospital or clinic, HPI does not compete directly with St. Jude Medical's CardioMEMS HF System or Medtronic's Reveal Linq. CardioMEMS, a wireless heart-monitoring device, was designed to manage chronic heart failure patients remotely. It won FDA approval in 2014.
FDA approved Edwards' Sapien XT transcatheter valve for use in valve-in-valve transcatheter aortic valve replacement (TAVR) procedure in March. XT TAVI valve will allow for minimally invasive surgery on adults and children who have a narrowed pulmonary valve, or moderate or greater pulmonary regurgitation caused by congenital heart disease.
Edwards plans a targeted commercial release of the software in Europe in 2016 and a full launch in 2017. It is not approved for commercial use in the U.S.
Nancy Crotti is a contributor to Qmed.
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