|[April 20, 2012]
Circuite® Provides Updated Clinical Data on Synergy® Miniature Ventricular Support System in Multiple Presentations at ISHLT Annual Meeting
SADDLE BROOK, N.J. & AACHEN, Germany --(Business Wire)--
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 (News - Alert) 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 systemwith 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.
In an oral session, Professor Meyns presented an abstract titled "A New
Treatment Option for INTERMACS Profile 4, 5 and 6 Patients with the
Circulite® Synergy® System" by B. Meyns, F. Rega, M. Strueber, A.
Barbone, E. Vitali and D. Burkhoff, which detailed an ongoing European
study of patients receiving Synergy system support (data presented on 50
patients). In patients who underwent follow-up right heart
catheterization at a median of 13 weeks (n=28), cardiac index increased
from 2.2 ± 0.5 L/min/M2 to 2.7 ± 0.5 L/min/M2
(p<0.001) and large reductions in capillary wedge pressure from 27.1 ±
9.6 mmHg to 17.5 ± 6.2 mmHg (p<0.001) were observed. In addition, with
the current data available from the ongoing trial, significant increases
in exercise tolerance, functional status and quality of life were
observed. Improvements made in the Synergy system used in the last 13
patients have significantly decreased the rate of overall severe adverse
events (events per patient-years). No strokes or other episodes of
neurologic dysfunction were reported in these last 13 patients. These
data support the notion that the Synergy system may provide clinical
benefits and, in clinical experience to-date, has a low adverse event
profile that helps justify treating this less sick patient population.
Another abstract titled "Reverse Remodeling With the Use of the
CircuLite® Synergy® Circulatory Assist System" by J. Geens, P. Claus, S.
Jacobs, M. Martin, I. Van Tichelen, F. Rega, D. Burkhoff and B. Meyns
was presented in an oral session by Professor Meyns. The team examined
preclinical models of chronic heart failure as well as 37 hearts at the
time of explants in patients undergoing heart transplantation (19
without cardiac support, 13 supported by HeartMate II and 5 by Synergy).
Across both preclinical and clinical analyses, six weeks of partial
ventricular unloading with the Synergy system induced remodeling of the
left ventricle. Hearts supported by the Synergy system had significantly
lower volumes and geometric distortion than those of chronically failing
unsupported hearts, as well as normalization of passive end-diastolic
pressure-volume relationships. These data were also reflected in the
clinical trial data, in which patients' cardiac indices increased over
the duration of support, suggesting that reverse remodeling did occur.
Additionally, one patient experienced myocardial recovery after 140 days
support; the Synergy micro-pump was explanted and the patient is doing
A poster titled "Two CircuLite Pumps as Bi-Ventricular Assist Device
(BVAD) in an Ovine Animal Model" by J.D. Schmitto, D. Burkhoff, M.
Avsar, O. Fey, P. Ziehme, G. Buechler, A. Haverich and M. Strueber was
also presented. Bi-ventricular support (simultaneous support of the left
and right ventricles) with two Synergy system micro-pumps was proven to
be feasible and able to provide full hemodynamic support in a
preclinical model. This approach holds promise for providing
bi-ventricular partial support in humans and, in particular, for full
support in small adults and children.
Synergy is a miniature ventricular support system that offers the
potential of a new minimally invasive treatment option for patients with
chronic heart failure who are not responding to standard medical care.
The system's less invasive implant procedure is intended to reduce the
surgical risks associated with implant procedures that require
cardiopulmonary bypass support. In addition, Synergy is intended to
reduce symptoms of heart failure and associated re-hospitalizations, as
well as to improve exercise tolerance and quality of life.
Synergy's micro-pump is the size of a AA battery, circulates up to 4.25
liters of blood per minute, and is intended to reduce the heart's
workload while improving blood flow to vital organs. Synergy supplements
the heart's native pumping capacity and preserves its ability to respond
to the patient's cardiac output demands. The system is surgically
implanted using a mini-thoracotomy and the micro-pump is placed in a
CircuLite is developing disruptive solutions to improve the treatment of
chronic heart failure. The Company's minimally invasive circulatory
support systems are intended to work in conjunction with the heart to
enhance clinical outcomes and improve quality of life for patients and
their families. Synergy®, currently in a CE Mark clinical trial,
features the world's smallest surgically implanted blood pump for
long-term use in patients diagnosed with heart failure. Next-generation
circulatory support systems in development that incorporate CircuLite's
micro-pump technology include an endovascular system, a right-heart
system, a pediatric system, and an all-support system. For more
information, visit our website at www.circulite.net.
CAUTION: Investigational Device. Limited by Federal Law to
Investigational Use Only.
CircuLite® and Synergy® are registered trademarks of CircuLite, Inc. in
the United States.
[ Back To TMCnet.com's Homepage ]