LivaNova has received the US Food and Drug Administration (FDA) 510(k) approval for extracorporeal membrane oxygenation (ECMO) for its LifeSPARC system.
LifeSPARC is the company’s next-generation Advanced Circulatory Support (ACS) pump and controller system, designed to remove the complexity associated with ECMO devices.
It is a centrifugal pump device that aids in circulating a patient’s blood and offers a simplified user interface and a simple navigation panel.
In July 2019, LifeSPARC was granted an initial 510(k) approval by the US FDA for use in cardiopulmonary bypass for up to six hours.
In April 2020, with the onset of the Covid-19 pandemic, the US health regulator issued temporary emergency guidelines for ECMO therapy beyond six hours.
The device was rapidly adopted by customers, to provide ECMO to critically ill patients during the Covid-19 pandemic, said LivaNova.
The FDA approval of the new indication is based on existing real-world evidence submitted by LivaNova, including the data collected during the Covid-19 pandemic.
With the FDA approval, LifeSPARC system can be now used for ECMO for more than six hours, with patients with acute respiratory failure or acute cardiopulmonary failure.
LivaNova ACS business unit president Ryan Miller said: “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.
“Since FDA published an enforcement policy to temporarily expand indications in 2020, many hospitals began using LifeSPARC and experienced its benefits firsthand. With the relative simplicity and portability of the system, more patients can have access to life-saving ECMO regardless of the hospital size where they are treated.”
LivaNova said that the LifeSPARC System was developed based on more than 20 years of life support experience with TandemHeart, the first-generation ACS system.
The system is said to have simplified the priming process and enhanced the power of the pump, while maintaining the strengths of its previous generation system.
Its on-patient pump design facilitates a miniaturised circuit, which makes it easy to transport within the hospital, and optimises circuit management for ICU staff.
Also, 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.
