LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (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.
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.
“LifeSPARC is the new generation pump and controller for the venerable Tandem system – a small but powerful heart pump with a magnetic bearing, a low-profile controller and a highly simplified user interface. I believe many more patients will have access to this higher level of support for the first time,” said Dr. David Baran, System Director for Advanced Heart Failure Transplant and Mechanical Circulatory Support at Sentara Heart Hospital in Norfolk, Va. “In particular, small- and mid-sized hospitals, which have historically had limited access to this type of technology, may now be able to provide this potentially life-saving therapy to critically ill cardiac and respiratory failure patients in need of Advanced Circulatory Support. The overall versatility of the LifeSPARC system may help to propel Mechanical Circulatory Support programs forward.”
“We are delighted to announce the upcoming availability of our new LifeSPARC system, and we believe this will become an essential asset in the hands of healthcare professionals,” said Damien McDonald, Chief Executive Officer of LivaNova. “Millions of patients are affected by cardiac and respiratory disease each year, and LifeSPARC was designed to ensure more of these patients can be supported with a single system that is simple enough for new practitioners and powerful enough for expert-level hospital centers.”
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.
In the U.S., the LifeSPARC system is intended to pump blood through an extracorporeal circuit for periods lasting less than six hours for the purpose of providing either: (i) full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.