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LivaNova Receives U.S. FDA 510(k) Clearance for Essenz Heart-Lung Machine for Cardiopulmonary Bypass Procedures
LONDON--(BUSINESS WIRE)-- LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology and innovation company, today announced it received U.S. Food and
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[{"type":"text","content":" LONDON--(BUSINESS WIRE)--\nLivaNova PLC (Nasdaq: LIVN), a market-leading medical technology and innovation company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Essenz™ Heart-Lung Machine (HLM). With FDA clearance, LivaNova initiates the commercial launch of Essenz in the U.S. 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, pediatric and neonatal patients in Europe. The Essenz HLM and Essenz™ Patient Monitor 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 cardiopulmonary bypass (CPB) procedures.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230309005787/en/LivaNova's Essenz™ Perfusion System (Photo: Business Wire)\n“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 in 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.”\n\nEssenz is based on 50 years of trusted partnership with perfusionists. LivaNova worked hand in hand with more than 300 perfusionists around the world who participated during every step of design and development to address their evolving needs in the operating room (OR), with an emphasis on patient safety and risk management.\n\nKey attributes of the Essenz Perfusion System include:\n\nSafe and Reliable:\n\nThe 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...