LivaNova (Nasdaq: LIVN) says a new FDA clearance expands how long health providers can use its LifeSparc advanced circulatory support (ACS) pump for extracorporeal membrane oxygenation (ECMO).
The new clearance makes permanent some of the temporary emergency guidelines under which LifeSparc provided ECMO therapy during the height of the COVID-19 pandemic.
In a news release posted yesterday, London-based LivaNova said it used existing real-world evidence to receive the new indication. The evidence included data collected during the pandemic.
“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 the 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,” Yau said in the news release.
More about LivaNova’s LifeSparc
The LifeSparc pump and controller system simplifies ECMO, according to LivaNova. The goal is to ensure that every hospital can access high-level life support. In addition, LivaNova designed LifeSparc’s controller to remove complexity. As a result, it has a streamlined user interface and a simple navigation panel.
The LifeSparc pump is centrifugal. Its creators designed it to reduce priming time to minutes. In addition, the on-patient pump design enables a miniaturized circuit. Therefore, it’s easy to transport within the hospital, optimizing circuit management for intensive care unit staff. LiveNova says health providers quickly adopted the LifeSparc to help patients during the COVID-19 pandemic.
LifeSparc’s initial 510(k) came in July 2019 for up to six hours of use for cardiopulmonary bypass. However, in April 2020, with the onset of the COVID-19 pandemic, the FDA issued temporary emergency guidelines for ECMO therapy beyond six hours. The temporary guidance included several products within the LivaNova ACS portfolio, including LifeSparc. They supported COVID-19 patients across the U.S.
The news 510(k) clearance allows the LifeSPARC system to be used for ECMO beyond six hours. The use beyond six hours is for people in acute respiratory failure or acute cardiopulmonary failure, including COVID-19 patients.
“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 Ryan Miller, president of the ACS business unit at LivaNova.
“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.”