Edwards Lifesciences (NYSE:EW) has announced that its Acumen hypotension prediction index (HPI) software has received FDA 510(k) clearance.
Using data obtained from the Acumen IQ finger cuff, the software uses machine learning to alert clinicians of the likelihood a patient is trending toward hypotension, or low blood pressure. Until now, Acumen HPI software has only been available for patients using an invasive arterial line, according to Irvine, Calif.-based Edwards.
“Numerous studies, including our research, have demonstrated an association between intraoperative hypotension and increased risk of acute kidney injury, myocardial injury and even death,” said Dr. Kamal Maheshwari, an anesthesiologist from Cleveland Clinic Foundation, in a news release from Edwards. “The noninvasive Acumen IQ cuff provides the opportunity to reduce hypotension in a broader range of patients, including those who do not require an invasive arterial line. The cuff, along with the predictive capabilities of Acumen HPI software to proactively manage hypotension, will have a meaningful impact on patients.”
The Acumen IQ cuff also provides access to automatically calculated, beat-to-beat hemodynamic parameters including mean arterial pressure and cardiac output. It will be available on the HemoSphere advanced monitoring system in the coming weeks, according to the company.
“This latest predictive technology demonstrates our commitment to patient care and providing clinicians with ‘smart’ monitoring tools that allow for better prediction and management,” said Katie Szyman, Edwards’ corporate VP, critical care. “We are extremely optimistic about launching Acumen IQ cuff and providing a tool to help clinicians make informed decisions for their patients, with the goals of reducing complications and helping patients with a quicker return to their families and their daily lives.”