Xenios AG concludes its first clinical study on i-cor Synchronized Cardiac Assist, documenting the safety and feasibility of the synchronized cardiovascular support system.
During the “SynCor” trial, a multicentre study treated 47 patients in nine different German clinics using an innovative pulsatile, cardiac-synchronous circulatory support system. The aim of the study was to collect prospective data on the performance and safety of i-cor Synchronized Cardiac Assist – a therapy mode of the CE-certified Xenios console. In the course of the study, 34 patients underwent cardiovascular therapy with i-cor due to a high-risk intervention on the coronary arteries while 13 patients were treated with i-cor due to cardiogenic shock.
Principal investigator Prof. Christoph Liebetrau from the Kerckhoff-Klinikum in Bad Nauheim presented the study results for the first time at the EURO PCR Congress in Paris on 22 May 2019. The results confirm that patients can be safely treated with i-cor Synchronized Cardiac Assist in both indication groups.
“Xenios AG would like to express its thanks to Prof. Liebetrau and all the centres that participated in this study. The results so far are reassuring, and they will have a significant role in advancing the development of cardiac-synchronous pulsatile circulatory support,” said PD Dr. Jürgen Böhm, Chief Medical Officer of Xenios AG.
The Synchritude Register, already in use in Germany, serves the purposes of post-market surveillance, helping collect additional prospective data on the performance of the i-cor Synchronized Cardiac Assist system in the context of combined heart-lung failure or high-risk interventions in the cardiac catheter laboratory.