LivaNova’s LifeSPARC Gains 510(k) Clearance for ECMO Use
LivaNova has received a new 510(k) clearance from the FDA for its LifeSPARC advanced circulatory support pump and controller system, this time for extracorporeal membrane oxygenation (ECMO) beyond six hours for patients with acute respiratory failure or acute cardiopulmonary failure.
Similar to the heart-lung by-pass process used in open heart surgery, ECMO is used when patients’ lungs cannot provide enough oxygen.
The LifeSPARC device first received 510(k) clearance in July 2019 for use in cardiopulmonary bypass for up to six hours. In April 2020, because of the COVID-19 pandemic, the FDA issued temporary emergency guidelines for ECMO therapy beyond six hours.
Earlier this year, the LifeSPARC System underwent a Class 1 recall because of a software malfunction which the company says has been resolved and cleared by the FDA.