On 20 April, CircuLite announced that updated clinical data related to the Synergy miniature ventricular support system was presented in two oral presentations and one poster session at the International Society for Heart and Lung Transplantation’s 32nd Annual Meeting and Scientific Sessions (ISHLT) in Prague, Czech Republic (18–21 April). The company also announced the successful implantation of the Synergy system in its 51st patient in the ongoing CE mark trial.
Updated results presented from the ongoing CE mark clinical trial for the Synergy system included significant improvements in haemodynamics, exercise capacity and quality of life in INTERMACS 4, 5 and 6 heart failure patients. A second presentation described the induction of positive physical changes to the left ventricle with the Synergy system, including size reductions toward normalcy (reverse remodeling). These data came from a study conducted in a preclinical model of heart failure and from a comparative analysis of explanted hearts conducted at the time of heart transplantation. A poster presentation discussed preclinical data supporting the feasibility of bi-ventricular support with two Synergy pumps.
“Approximately 90% of the patients in the ongoing CE mark trial were classified as INTERMACS 4, 5 and 6. The risk of currently marketed cardiac support device implantation could be considered too high for many in this group, yet these patients are very sick and their quality of life is severely impacted,” said Bart Meyns, professor and chief of Cardiac Surgery at Gasthuisberg University Hospital and clinical advisor to CircuLite. “The Synergy system is implanted in an off-bypass procedure and results from early clinical experience for this first-of-its-kind technology are encouraging and support the potential for Synergy to treat a larger proportion of heart failure patients who are not responding to standard medical care and are not candidates or eligible for heart transplantation.”
“CircuLite is establishing its leadership position in developing less invasive circulatory assist systems with the world’s smallest implantable blood pump technology for long-term use,” said Paul Southworth, president and CEO, CircuLite. “Surpassing the 50th patient milestone in our ongoing CE mark trial demonstrates that CircuLite is making strong clinical progress with Synergy as we plan to advance the system with CE mark in the coming months, initiate a US pilot trial with Synergy and continue to advance our strong pipeline of next-generation circulatory support systems.”
CircuLite’s Synergy system includes a micro-blood pump the size of a AA battery that can be implanted superficially in a “pacemaker-like” pocket. Synergy is the first and smallest surgically implanted device designed for partial circulatory support (up to 4.25L/min) in patients with heart failure. CircuLite is currently conducting a clinical trial with Synergy in patients with Class IIIB/early Class IV heart failure at multiple centers in Europe, aimed at achieving CE mark.