LivaNova PLC, a medical technology and innovation company, recently announced it has received FDA’s 510(k) clearance for extracorporeal membrane oxygenation (ECMO) for its LifeSPARC system. The LifeSPARC pump and controller system is a next-generation Advanced Circulatory Support (ACS) pump and controller system.
The LifeSPARC controller was designed to remove the complexities often associated with ECMO devices, instead using a streamlined user interface and simple navigation panel, according to LivaNova. The pump is centrifugal and designed to reduce priming time to only minutes. Additionally, it is designed to allow for a miniaturized circuit, making it easy to move throughout the hospital and optimizing circuit management for intensive care unit staff. 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 a part of an extracorporeal circuit, including physiologic gas exchange. The system 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 risk of death is imminent.
The system received an initial 510(k) clearance in July 2019 for up to six hours of use for cardiopulmonary bypass. Then, in April 2020 at the onset of the COVID-19 pandemic, the FDA issued temporary emergency guidelines for ECMO therapy beyond six hours. Several products within the company’s portfolio, including LifeSPARC, were included in the temporary guidance and made available to support COVID-19 patients across the United States. Due to its availability and mobility, according to the company, there was swift adoption of the device, providing ECMO to critically ill COVID-19 patients.
The latest clearance now 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. LivaNova leveraged existing real-world evidence inclusive of data collected during the COVID-19 pandemic to receive the 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.”
LivaNova also noted that as of Nov. 8, it has achieved 100% customer response rate for the LifeSPARC Critical Failure field action, which was required by the FDA under a recent recall and related to modifications made to the operations manual for the controller. These modifications were made to address situations where certain users were unintentionally stopping the pump in response to a screen error message. As part of the recent clearance, the software updates were reviewed and cleared by the FDA, allowing LivaNova to contact its customers to implement the updates.