LivaNova (Nasdaq:LIVN) announced today that it received FDA 510(k) clearance for its Essenz heart-lung machine (HLM).
With clearance, the London-based company initiated its U.S. commercial launch for Essenz, too. It recently received approval for Essenz HLM from Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). In February, LivaNova kicked off a limited commercial launch for Essenz in Europe, too.
LivaNova said in a news release that it now plans to start a broad European launch after success in its limited rollout. The limited launch supported more than 200 adult, pediatric and neonatal patients in Europe.
LivaNova designed the Essenz system with a next-generation heart-lung machine and a patient monitor. The company built it to deliver a patient-tailored approach. This approach supports data-driven decisions during 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,” said Larry Garrison, chief perfusionist at Franciscan Health (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.”
About the LivaNova Essenz HLM
LivaNova collaborated with more than 300 perfusionists during the design and development process for Essenz. It aimed to develop a system with flexibility and scalability, optimizing intraoperative care coordination.
The system also includes an ergonomic design with advanced cable management. It features a mast-mounted design for hygiene purposes. Essenz’s cockpit offers one central view to control the device, check all perfusion and monitor patient parameters.
Essenz builds upon the LivaNova S5 HLM system. Its patient monitor and HLM cockpit connect but operate separately. Additionally, each pump on Essenz is controlled individually. The system features accurate sensing technology and an intuitive dashboard on the patient monitor. Essenz’s HLM sensor checks confirm readiness before the CPB procedure starts.
LivaNova said it created the system with patient-tailored care in mind. It utilizes official formulas to support perfusionists as they implement goal-directed perfusion, a therapy for reducing the risk of acute kidney injury.
The intuitive system automatically and seamlessly transfers data, minimizing manual data entry. LivaNova said it built the platform to accommodate a stream of future software features and functionalities, too.
“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.”