LivaNova’s Essenz Heart-Lung Machine Earns FDA Nod

LivaNova has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Essenz heart-lung machine (HLM). The company also recently received approval for the Essenz HLM from Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
 
LivaNova also began a broad commercial release in Europe. The Essenz HLM and Essenz patient monitor make up the Essenz perfusion system, which permits patient-tailored perfusion rooted in data-driven decisions for cardiopulmonary bypass (CPB) procedures.
 
“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, Chief Perfusionist at Franciscan Health Indianapolis told the press. “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 CPB procedures.”
 
The system is built on the LivaNova S5 HLM, which has supported millions of patients. Each Essenz pump is controlled individually and the HLM sensor checks confirm readiness before CPR begins. Sensing tech and a dashboard on the Essenz patient monitor provide data to support individualized, data-driven patient care.
 
The patient monitor uses formulas to support implementation of goal-directed perfusion (GDP), a therapy effective to reduce the risk of acute kidney injury. Mast-mounted pumps help optimize position of the disposables to minimize priming volumes and reduce hemodilution.
 
“A perfusion system acts as a patient’s heart and lungs during an open-heart procedure, so having the highest-quality system backed by the expertise of a skilled perfusionist is paramount,” said Damien McDonald, CEO of LivaNova. “When we were designing Essenz, perfusionists told us they needed a system that gives them access to comprehensive data to drive more informed decision-making throughout the entire procedure. We’ve done that with Essenz. Through next-generation hardware and software, Essenz empowers perfusionists to better serve their patients with increasingly tailored care.”