UK-based LivaNova said it received 510(k) clearance from the U.S. Food and Drug Administration for its Essenz Heart-Lung Machine, which is paired with LivaNova’s patient monitor to create a perfusion system used during cardiopulmonary bypass procedures. A perfusion system acts as a patient’s heart and lungs during an open-heart procedure.

“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, who participated in the Essenz validations, said in a statement.

LivaNova CEO Damien McDonald called the cardiopulmonary market “large, durable and growing,” and estimates it at about $2 billion a year, where capital equipment like the Essenz system represents about $800 million and disposables about $1.2 billion. While there are a few competitors in the space, LivaNova is the market leader with an estimated 70% share in heart-lung machines and an installed base of at some 7,000 units worldwide.

“We anticipate a gradual ramp with Essenz capital sales, picking up by mid-2023 in Europe and in the U.S.,” McDonald said in an email to MedTech Dive. Development of the Essenz system began in 2017.

The Essenz Perfusion System can be adapted to adult and pediatric patients. It has a mast-mounted design to minimize distractions and keep the area clean. The cockpit provides one central view to control the device and check all perfusion and patient parameters. Also, Essenz integrates with operating room external devices and hospital information systems.