Revolutionary Miniature Blood Pump from CircuLite Successfully
Implanted in First Chronic Heart Failure Patient
-Synergy Device Designed to Provide Partial Circulatory Assist in
Patients with Chronic Heart Failure-
HACKENSACK, N.J. and AACHEN, Germany (Business Wire EON/PRWEB ) August 8, 2007 --
CircuLite™, Inc. today reported the launch of
the Company’s clinical development program for
its Synergy™ Pocket Circulatory Assist Device
with the successful implantation of the first patient in a European
feasibility trial. Synergy is a miniature implantable blood pump, the
size of a AA battery, that can be implanted superficially in a pocket,
like a pacemaker. The device is designed to provide long-term, partial
circulatory support in patients with chronic heart failure. The primary
objective of the first-in-man trial is to assess the safety of the
device in patients with chronic heart failure who are waiting to receive
heart transplants. Bart Meyns, M.D., Ph.D., Professor and Chief of
Cardiac Surgery at Gasthuisberg University Hospital (Katholieke
Universiteit) in Leuven, Belgium, performed the first implant.
“The first implant of the Synergy device was
very successful and the patient has already been discharged home and is
doing very well,” said Prof. Meyns, Principal
Investigator of the trial. “While CircuLite’s
feasibility clinical study is in a bridge-to-transplant setting, the
ultimate need for this type of device will be among those chronic heart
failure patients who may not be eligible for a heart transplant. A
partial support approach to chronic heart failure treatment may be
better able to address the treatment needs and improve the quality of
life for this unserved group of patients, who otherwise have no other
options.”
The CircuLite technology is designed to provide a new treatment option
for over two million chronic heart failure patients worldwide who
continue to be significantly symptomatic despite appropriate, optimal
medical and device-based therapies. While feasibility studies will
examine the hemodynamic and clinical effects of the Synergy device in
patients that are awaiting heart transplants, CircuLite’s
ultimate goal is to expand the treatment of heart failure to the
chronic, ambulatory patient in order to improve their quality of life by
giving them an elective, less-invasive option to increase blood flow
from the heart.
“The first-in-man implant of our Synergy
device is a significant milestone not only for our company, but for the
chronic heart failure community as a whole, especially patients, who we
hope will someday benefit from this potentially life-changing therapy,”
said Paul Southworth, President and CEO of CircuLite. “CircuLite
is striving to transform the treatment model for this condition to
long-term, partial circulatory support. The commencement of this trial
is an achievement that brings together over 11 years of engineering and
research and demonstrates our leadership position in this space. This
trial will provide us with important data to support our additional
planned studies, including a CE Mark trial in Europe, as well as our
Investigational Device Exemption (IDE) trials in the United States.”
The Phase I study will include up to three European hospitals and will
enroll chronic heart failure patients who are awaiting heart
transplantation and whose heart function is in a state of decline.
Patients will be surgically implanted with the device. The trial will
evaluate the safety of the device for up to six months. CircuLite
developed this trial to evaluate Synergy in a surgical,
bridge-to-transplant setting in order to collect initial data to
establish clinical proof-of-concept; however, the further development of
the device will be focused on non-surgical, endovascular implantation
for use as a long-term therapy.
“The current trial design is an important
first-step for our Synergy device, but our eventual plan is to utilize a
minimally invasive procedure and for patients to be implanted with the
device sooner, before they have reached the later stages of chronic
heart failure. This treatment paradigm would ensure that patients could
benefit as much as possible from this long-term therapy,”
said Daniel Burkhoff, M.D., Ph.D., CircuLite’s
Medical Director and Adjunct Associate Professor of Medicine at Columbia
University Medical School.
About Synergy™
The Synergy Pocket Circulatory Device is a small implantable blood pump
designed to provide long-term, partial circulatory support to patients
with chronic heart failure. The key component of the Synergy device is
the proprietary and patented micro-pump technology acquired after eight
years of development at the Helmholtz Institute in Aachen, Germany, one
of the world’s leading centers for blood pump
technology development, in collaboration with Katholieke Universiteit in
Leuven, Belgium. The device is designed to be small enough to be
implanted subcutaneously in the “pacemaker
pocket” through a minimally invasive
procedure. Synergy is designed to supplement the heart’s
native pumping function, potentially increasing blood flow and allowing
the heart to rest and potentially recover, possibly improving the
quality of life of chronic heart failure patients. The CircuLite
technology may provide a new treatment option for millions of chronic
heart failure patients worldwide who continue to be significantly
symptomatic despite appropriate, optimal medical therapy.
About CircuLite™
CircuLite is developing a miniature blood pump, designed to be placed
superficially like a pacemaker, for the long-term treatment of chronic
heart failure. The Synergy Pocket Circulatory Assist device is designed
to rest a failing heart by supplementing its natural function. By
providing long-term circulatory assist on a minimally invasive platform,
CircuLite’s Synergy has the potential to
transform the management of chronic heart failure and improve the
quality of life for millions of patients and their families. For more
information on CircuLite and the Synergy Pocket Circulatory Assist
device, visit our website at www.CircuLite.net.
CAUTION: Investigational Device. Limited by Federal Law to
Investigational Use Only.
CircuLite™ and Synergy™
are trademarks of CircuLite, Inc. in the United States.
MULTIMEDIA GALLERY http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5466979
See the original story at: http://eon.businesswire.com/releases/synergy/device/prweb545582.htm
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