Heart-lung machine nets FDA 510(k) clearance, launched in US
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LivaNova announced it received FDA 510(k) clearance for its heart-lung machine and initiated the commercial launch of the machine in the U.S.
The heart-lung machine and accompanying patient monitor comprise a system (Essenz Perfusion System) designed to improve both clinical workflow and quality of patient care during cardiopulmonary bypass, according to a press release from the company.
Features of the perfusion system include sensor checks to confirm readiness prior to cardiopulmonary bypass, according to the release.
The patient monitor utilizes formulas to support perfusionists in reducing the risk for acute kidney injury, as well as mast-mounted pumps designed to allow the operator to optimize the position of disposables, minimizing priming volumes and reducing hemodilution, according to the release.
The system is also designed to automatically transfer patient data to minimize manual data entry and can be adapted to adult and pediatric workflows.
“The Essenz Perfusion System has tremendous potential to become a key addition to our clinical practice, fusing a new era of technology with the skill and expertise of the perfusionist,” Larry Garrison, PhD, MBA, CCP, chief perfusionist at Franciscan Health Indianapolis, said in the release. “Since we participated in the Essenz HLM validations and the early release of the Essenz Patient Monitor, we’ve witnessed the system’s immense ability to unlock the potential of individualized care throughout all phases of [cardiopulmonary bypass] procedures.”
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