510(k) clearance for extracorporeal membrane oxygenation for LifeSPARC, the next-generation advanced circulatory support system

LivaNova leveraged existing real-world evidence inclusive of data collected during the COVID-19 pandemic to receive this 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,” 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.”

LifeSPARC 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 510(k) clearance allows for the LifeSPARC system to be used for ECMO beyond six hours with patients in acute respiratory failure or acute cardiopulmonary failure, including but not limited to those receiving treatment for COVID-19.

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.

Notably, as of November 8, LivaNova achieved a 100% customer response rate for the LifeSPARC Critical Failure (CF) field action, which was required by FDA under a recent recall and related to modifications made to the Operations Manual for the LifeSPARC controller to address situations during which 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 have been reviewed and cleared by FDA, thus allowing LivaNova to contact customers to implement the updates.