Medical technology company LivaNova received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Essenz Heart-Lung Machine (HLM).
The Essenz HLM and Essenz Patient Monitor comprise the Essenz Perfusion System, which enables a patient-tailored perfusion approach rooted in data-driven decisions that improve both clinical workflows and quality of patient care during cardiopulmonary bypass (CPB) procedures.
“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,” says Damien McDonald, Chief Executive Officer 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.
With the FDA clearance, LivaNova initiates the commercial launch of Essenz in the U.S. The company also recently received approval for the Essenz HLM from Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
“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,” says Larry Garrison, chief perfusionist at Franciscan Health Indianapolis in Indianapolis, Indiana. “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.”
LivaNova says it worked with more than 300 perfusionists around the world who participated during every step of design and development to address their evolving needs in the operating room (OR), with an emphasis on patient safety and risk management.
Featured image: LivaNova’s Essenz Perfusion System Photo: Business Wire