LivaNova has announced the receipt of US Food and Drug Administration (FDA) 510(k) clearance for its Essenz heart-lung machine (HLM), initiating the commercial launch of the system in the USA.
The company also recently received approval for the Essenz HLM from Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Additionally, LivaNova is initiating a broad commercial release in Europe, following a successful limited commercial release that supported more than 200 adult, paediatric and neonatal patients in Europe.
“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,” said Larry Garrison (Franciscan Health Indianapolis, Indianapolis, USA). “Since we participated in the Essenz HLM validations and the early release of the Essenz Patient Monitor, we have witnessed the system’s immense ability to unlock the potential of individualised care throughout all phases of cardiopulmonary bypass 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,” said 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.”