FDA clears new LivaNova heart-lung machine for cardiopulmonary bypass procedures
LivaNova PLC announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Essenz Heart-Lung Machine (HLM). The company developed the new cardio-pulmonary system based on feedback from more than 300 perfusionists address their evolving needs in the operating room (OR).
The Essenz HLM and Essenz Patient Monitor comprise the new perfusion system, which the company said 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.
“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 in Indianapolis, said in a statement. “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 vendor said there are several key attributes of the new system:
• Each pump is controlled individually for simple, straightforward operations.
• HLM sensor checks confirm readiness before the CPB procedure starts.
• Patient-tailored care with accurate sensing technology and an intuitive dashboard to provide critical data to support individualized, data-driven patient care during a case.
• The patient monitor utilizes formulas to support perfusionists in the implementation of goal-directed perfusion (GDP), a therapy effective in reducing the risk of acute kidney injury.[1]
• Mast-mounted pumps allow the user to optimize the position of the disposables, such as the oxygenator and perfusion tubing set. This can minimizes priming volumes and reduces hemodilution.
• The patient monitor has 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 in the OR. The technology platform is built to accommodate a stream of future software features and functionalities.
The company also recently received approval for the Essenz HLM from Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). LivaNova is also initiating a broad commercial release in Europe, following a successful limited commercial release that supported more than 200 adult, pediatric and neonatal patients in Europe.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com