The US Food and Drug Administration (FDA) has granted London-based LivaNova 510(k) clearance for its Essenz Heart-Lung Machine (HLM) for cardiopulmonary bypass (CPB) procedures. With the clearance, LivaNova initiates the commercial launch of Essenz in the US.
The Essenz HLM and Essenz Patient Monitor, which received FDA clearance in November 2021, 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 CPB procedures,” according to a press release by LivaNova.
“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, PhD, chief perfusionist at Franciscan Health Indianapolis, in a press 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 CPB procedures.”
According to LivaNova, key attributes of the Essenz Perfusion System include:
- Safe and reliable: The system is built on the proven LivaNova S5 HLM, which has supported millions of patients for safe CPB procedures. Each pump on Essenz is controlled individually for simple, straightforward operations. HLM sensor checks confirm readiness before the CPB procedure starts. The Essenz HLM cockpit and Essenz Patient Monitor are connected but operate separately to further ensure reliability.
- Patient-tailored care: Accurate sensing technology and an intuitive dashboard on the Essenz Patient Monitor provide critical data to support individualized, data-driven patient care during a case. Essenz Patient Monitor utilizes official formulas to support perfusionists in the implementation of goal-directed perfusion, a therapy effective in reducing the risk of acute kidney injury. Mast-mounted pumps allow the user to optimize the position of the disposables (i.e. oxygenator and perfusion tubing set), which minimizes priming volumes and reduces hemodilution.
- Intuitive: The Essenz Patient Monitor offers an intuitive user interface and continuously records and displays data and events together to assist the perfusionist throughout a procedure. Data is automatically and seamlessly transferred, minimizing manual data entry and freeing up valuable time for the perfusionist.
“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, LivaNova CEO, in a press release. “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.”
LivaNova also recently received approval for the Essenz HLM from Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency. LivaNova is initiating a broad commercial release in Europe, following a successful limited commercial release that supported more than 200 adult, pediatric, and neonatal patients in the country.
Photo caption: LivaNova’s Essenz Perfusion System (Photo: Business Wire)