Results of study at Charles University’s Na Homoice Hospital, Prague, Czech Republic, presented at American Heart Association (AHA) annual meeting
HEILBRONN, Germany, Dec. 10, 2015 — XENiOS® announced today that its i-COR®Synchronized Cardiac Assist Systemprotects left ventricular (LV) function compared to continuous-flow ECLS (extracorporeal life support) in cardiogenic shock.
Study data were presented at the recent American Heart Association (AHA) annual meeting in Orlando, Fla., by principal investigator Petr Oštádal, M.D., Ph.D., Charles University, Na Homolce Hospital, Prague, Czech Republic. In the Oštádal study, myocardial hypoxia resulted in a decline in mean (±SD) cardiac output to 2.3±1.2 L/min, systolic blood pressure to 61±7 mmHg and LV ejection fraction (EF) to 21±7%. Synchronized pulsatile flow was associated with significant reduction of LV end-systolic volume (ESV), increase in LV stroke volume (SV), and higher EF at all ECLS flow levels compared to continuous ECLS flow. At selected ECLS flow levels, pulsatile flow reduced also LV end-diastolic pressure (EDP), end-diastolic volume (EDV), and systolic pressure (SP).
“The i-cor Synchronized Cardiac Assist System enables a whole new chapter in ccardiac support,” said Georg Matheis, M.D., Managing Director of XENiOS. “With synchronized cardiac assist, the i-cor system is the world’s first to harmonize mechanical circulatory support with the heartbeat. This innovation not only opens up new therapy options for patients who are suffering from cardiogenic shock, but also serves to bridge patients across high-risk interventions in the cardiac cath lab.”
Patients with cardiogenic shock have a very high mortality rate. Cardiogenic shock is a medical emergency. Cardiogenic shock results from an inadequate circulation of blood due to primary failure of the heart ventricles to function effectively. As this is a type of circulatory shock, there is insufficient perfusion of tissue. The condition involves increasingly more pervasive cell death from oxygen starvation (hypoxia).
Synchronized Cardiac Assist “overlays” or “superimposes” a physiological pulse wave onto the patient’s weakened pulse and is designed to be a less invasive treatment than the current standard while using a more physiological treatment designed to be essential to endothelial function, which ensures adequate tissue perfusion in the organs. Maintaining organ function serves to prevent multi-organ failure and to improve clinical outcomes. The energy of synchronized pulsatility in conjunction with the i-cor Synchronized Cardiac Assist device allows for a reduction of invasiveness compared to standard care by reducing blood flow and thus reducing cannula size. As a result, i-cor is designed to offer physiological cardiac assist, protection, and safety during interventions in the cardiac cath lab, as well as for the management of cardiogenic shock in the ICU and the cardiac cath lab.
About XENiOS®
XENiOS AG is a privately held medical device company that is comprised of two therapy brands, novalung® and i–cor®, that run on a single XENiOS platform. XENiOS novalung offers the full spectrum of extrapulmonary lung support. XENiOS i-cor is focused on heart therapies. The XENiOS platform is designed for physicians to treat the same patient who either has certain singular lung or heart issues, or has concomitant lung and heart issues, with one platform of minimally invasive products that do not require mechanical ventilation, sedation, and immobility. XENiOS AG is the only company that can make this claim.
