CircuLite starts European trial for Synergy cardiac assist device
19 March 2008
CircuLite, Inc. has announced a 20-patient trial for its Synergy
circulatory assist device that is designed to lead to CE Mark approval
in the European Union for long-term implantation in heart failure
patients.
Synergy is a micro implantable blood pump, the size of an AA battery,
that can be implanted superficially in a 'pacemaker-like' pocket. The
device is designed to provide long-term, partial circulatory support in
patients with chronic heart failure.
This announcement follows successful completion of a first-in-man
pilot study of Synergy in four patients. “As a result of the success of
our first-in-man pilot trial, we have embarked on this European approval
trial for the long-term use of Synergy,” said Paul Southworth, President
and CEO of CircuLite.
“We believe that Synergy represents a potential breakthrough for the
long-term support of the millions of patients with chronic heart failure
who remain symptomatic despite optimal medical management, and, if
eligible for a heart transplant, may need to wait more than 12 months
for the procedure.”
The European registration trial is planned to enroll 20 patients with
chronic heart failure and will evaluate the safety and patient quality
of life improvements associated with device support of greater than six
months.
To-date, seven patients have been successfully implanted with the
Synergy device. Six implants were performed by Dr Bart Meyns at
Gasthuisberg University Hospital (Katholieke Universiteit) in Leuven,
Belgium, the site of the first-in-man trial. One patient in the trial
was implanted at Hannover Medical School in Hannover, Germany, by Dr
André Simon, Managing Doctor of the Thoracic Transplant Program, and Dr
Martin Strüber, Director of the Thoracic Transplant Program. Three
patients are currently on device support and are doing well. The Company
also announced today that a third trial site, University Hospital in
Münster, Germany, has completed training and is now screening patients
for the CE Mark trial.
“We are pleased to have two new, highly respected European trial
sites and surgical teams on board for Synergy’s clinical program,”
commented Southworth. “The addition of these sites highlights the
interest in, and need for, this type of device.”
CircuLite recently reported positive results from the European
first-in-man pilot study, for which enrollment is now complete. Four
patients were implanted with Synergy in this trial. These patients
benefited from significant improvements in haemodynamics and were
allowed to return to activities of daily living. All patients reached
the primary endpoint of successful heart transplantation, with one
patient supported for seven months.