Edwards Lifesciences Corp. recently received FDA clearance for its ForeSight tissue oximetry device, its latest noninvasive medical device capable of measuring the oxygenation of brain tissue.
The company’s HemoSphere platform provides monitoring of hemodynamics, which is blood flow; more comprehensively, it includes the heart’s ability to profuse blood throughout the circulatory system. During surgery, a team in place monitors a patient’s hemodynamics.
The function of HemoSphere is to anticipate possible disruptions in oxygenation allowing physicians to intervene before a complication would occur.
The ForeSight device monitors disruption of oxygen in the brain.
“Physicians will hopefully become more dependent on this,” corporate vice president of critical care, Katie Szyman, told the Business Journal.
The artificial intelligence used in the HemoSphere technology is capable of detecting a loss of hemodynamics 15 minutes in advance—which “actually is a really long time” because when surgeons are operating on a patient, every second counts, Szyman said.
“Understanding the relationship between the heart and the brain can provide valuable patient insights” to clinicians, she said.
“And really, HemoSphere is measuring how much oxygen is being pumped out by the heart and then the cerebral oximetry device measures the oxygenation of the brain—I call it the ‘namaste deal’ because” it gives peace of mind.
In terms of oxygenation, the brain prioritizes itself, but keeps its extracellular fluid separated by the blood-brain barrier, which prevents possible pathogens from entering the brain. For this reason, a separate diagnostic analysis tool such as ForeSight is needed to determine oxygenation.
A Good Heart
Earlier this month, Edwards reintroduced its Partner 3 trial results for the Sapien 3 delivery system and heart valve at the Transcatheter Cardiovascular Therapeutics’ 31st annual symposium in San Francisco.
The results of the Partner 3 trial emphasized at the TCT symposium included the additional categorical demographic of “low-risk” patient populations, which is a huge win for patients since more will now be able to receive the less invasive route to obtaining a replacement heart valve.
Previously, TAVR procedures that utilize the Sapien 3 device had only been approved for moderate-risk and high-risk populations—high-risk for open-heart surgery, but a candidate for TAVR. Now, all patient risk-populations are represented for FDA use.
Edwards (NYSE: EW) stock has risen about 60% this year to around $226 a share and a $47 billion market cap.
