LivaNova’s LifeSPARC Earns FDA Nod for ECMO

LivaNova has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for extracorporeal membrane oxygenation (ECMO) with its LifeSPACE next-gen advanced circulatory support (ASC) pump and controller.
 
The company leveraged real-world data collected during the COVID-19 pandemic to receive the new indication.
 
“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,” Dr. Raymond Yau, Director of Cardiogenic Shock at Heart Hospital of New Mexico told the press. “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.”
 
LifeSPARC aims to simplify ECMO to hospitals of all sizes can access the life support. It was designed to remove complexity often seen with ECMO devices, offering a streamlined user interface and simple navigation panel.
 
The LifeSPARC pump is centrifugal and reduced priming time to minutes. An on-patient pump design allows for a miniaturized circuit for easy transport and optimizing circuit management. Its console and pump are complemented by four ready-to-deploy kits with a variety of cannulation configurations.
 
It initially received FDA clearance in July 2019 for up to six hours of cardiopulmonary bypass. In April 2020 the FDA issued temporary emergency guidelines for ECMO therapy beyond six hours—several LivaNova ACS products were made available to support COVID-19 patients in the U.S.
 
The latest clearance allows for LifeSPARC to be used for ECMO beyond six hours for acute respiratory failure or acute cardiopulmonary failure.
 
“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.”
 
As of November 8, LivaNova achieved a 100% customer response rate for the LifeSPARC Critical Failure (CF) field action, required by FDA under a recent recall and related to modifications made to the Operations Manual for the LifeSPARC controller to address situations where certain users were unintentionally stopping the pump in response to a screen error message. As part of the 510(k) clearance, LifeSPARC controller software updates were reviewed and cleared by FDA, thus allowing LivaNova to contact customers to implement the updates.