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LivaNova Receives 510(k) Clearance for ECMO from FDA for LifeSPARC, the Next-generation Advanced Circulatory Support System
Platform simplifies life support, making life-saving technology more accessible to hospitals and critically ill patients LONDON--(BUSINESS WIRE)-- LivaNova
About this update from Livanova Plc
[{"type":"text","content":"\nPlatform simplifies life support, making life-saving technology more accessible to hospitals and critically ill patients\n\n LONDON--(BUSINESS WIRE)--\nLivaNova PLC (Nasdaq: LIVN), a market-leading medical technology and innovation company, today announced it received 510(k) clearance for extracorporeal membrane oxygenation (ECMO) from the U.S. Food and Drug Administration (FDA) for LifeSPARC™, the Company’s next-generation Advanced Circulatory Support (ACS) pump and controller system. LivaNova leveraged existing real-world evidence inclusive of data collected during the COVID-19 pandemic to receive this new indication.\n\n“The onset of the global pandemic elevated ECMO to the forefront as an effective treatment option for patients in need of emergent rescue who had limited, if any, options,” said Dr. Raymond Yau, Director of Cardiogenic Shock at Heart Hospital of New Mexico in Albuquerque. “The past couple of years have demonstrated the inherent value of the LifeSPARC system, which offers even the sickest patients a chance at survival. With LifeSPARC, simplified and streamlined ECMO is in reach for healthcare centers of all sizes.”\n\nThe LifeSPARC pump and controller system simplifies ECMO to ensure that hospitals of all sizes can access this high level of life support. The LifeSPARC controller was designed to remove complexity often seen with ECMO devices, instead offering a streamlined user interface and simple navigation panel. This simplicity increases accessibility and ease of use for hospital staff. The LifeSPARC pump is centrifugal and designed to reduce priming time to minutes. The on-patient pump design allows for a miniaturized circuit, making it easy to transport within the hospital and optimizing circuit management for intensive care unit staff. This led to swift device adoption by customers, providing ECMO to critically ill patients during the COVID-19 pandemic.\n\nLifeSPARC received an initial 510(k) FDA clearance in July 2019 for up to six hours of use for cardiopulmonary bypass. In April 2020 and with the onset of the COVID-19 pandemic, the FDA issued temporary emergency guidelines for ECMO therapy beyond six hours. Several products within the LivaNova ACS portfolio, including LifeSPARC, were included in the temporary guidance and thereby made available to support COVID-19 patients across the U.S. This latest...