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
“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.
The 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.
LifeSPARC received an initial 510(k) FDA clearance in
“There is a growing need for simplified life support and with the LifeSPARC pump and controller, we have the opportunity to make ECMO an option for more patients in more places,” said
The LifeSPARC System was built on more than 20 years of life support experience with TandemHeart™, the first-generation ACS system. LifeSPARC simplified the priming process and increased the power of the pump, while leveraging the strengths of the previous generation system. The console and pump are complemented by four ready-to-deploy kits that offer a variety of cannulation configurations to support cardiac and cardiopulmonary conditions. LifeSPARC assists in circulating a patient’s blood when part of an extracorporeal circuit, including physiologic gas exchange. It is intended for use in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
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This news release contains “forward-looking statements” concerning the Company’s goals, beliefs, expectations, strategies, objectives, plans and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding LifeSPARC and the ACS product portfolio. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company’s most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
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