Inc. today 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. 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 hemodynamics,
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 percent 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, M.D., Ph.D., 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 Chief Executive Officer of 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 U.S. 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.