Edwards wins FDA nod for next-gen HemoSpher platform
Edwards Lifesciences (NYSE:EW) said yesterday that it won FDA 510(k) clearance for its Hemosphere platform with the Acumen suite of decision-support solutions intended for hemodynamic monitoring.
The Irvine, Calif.-based company touted that the newly cleared HemoSphere platform is the first to include predictive monitoring for moderate to high-risk surgical patients.
The system now includes the Acumen hypotension prediction index, a machine-learning powered algorithm intended to indicate the likelihood of a hypotensive event, and the Acumen IQ sensor, which allows the HPI software to update parameters every 20 seconds, Edwards said.
“Combining the Swan-Ganz catheter and the FloTrac sensor with the Acumen suite and the hypotension prediction index software on the HemoSphere platform presents a powerful integration of hemodynamic information. The common interface simplifies the workplace for clinicians while providing comprehensive guidance to optimize and individualize patient care,” Edwards consultant Dr. Neal Fleming of the UC Davis School of Medicine said in a prepared statement.
“With the addition of the Acumen suite, the HemoSphere platform is a cornerstone solution that integrates a range of advanced hemodynamic monitoring solutions and decision-support tools to address patient needs in a range of clinical settings. Moving forward, Edwards plans to continue to evolve and expand the machine learning algorithms to ensure clinical relevance in surgical and intensive care unit settings, to truly establish HemoSphere as the platform of the future,” Edwards critical care corp VP Katie Szyman said in a press release.
This week, Edwards Lifesciences launched a pivotal tiral of its Pascal mitral valve repair system, touting that th first procedure was performed this week at Atlantic Health System’s Morristown Medical Center.