FDA 510(k) clearance for LifeSPARC system advanced circulatory support (ACS) pump
LivaNova PLC announced it has received 510(k) clearance from the FDA for its new Advanced Circulatory Support (ACS) pump and controller, the LifeSPARC system. Derived from more than 20 years of life support experience with TandemLife, LifeSPARC begins a new chapter for ACS innovation within the LivaNova portfolio.
LivaNova expects to commence the limited commercial release of LifeSPARC in the United States later this year, with full commercial release expected by the end of 2019. Availability in other countries is anticipated to begin in 2020.
Built around a common compact console and pump, LifeSPARC provides temporary support for emergent rescue patients in a variety of settings. Designed for ease of use, the system offers more power and versatility for multi-disciplinary programs to support more patients. The system is accompanied by four specialized and ready-to-deploy kits, each designed to support diverse cannulation strategies.