CircuLite Announces Initiation Of European Registration Study For Synergy(TM) Circulatory Assist Device

Main Category: Medical Devices
Also Included In: Cardiovascular / Cardiology
Article Date: 10 Mar 2008 - 1:00 PDT

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CircuLite™, Inc. announced that the Company has advanced its Synergy™ Pocket Circulatory Assist Device clinical program into a 20-patient trial designed to lead to CE Mark approval in the European Union for long-term implantation of Synergy in heart failure patients. This announcement follows successful completion of a first-in-man pilot study of Synergy in four patients. Synergy is a micro implantable blood pump, the size of a 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.

"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 Bart Meyns, M.D., Ph.D., 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 André Simon, M.D., Managing Doctor of the Thoracic Transplant Program, and Martin Strüber, M.D., 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 hemodynamics 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 7 months.

About Synergy™

The Synergy Pocket Circulatory Assist device is a small implantable blood pump designed to provide long-term, partial circulatory assist 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 small enough to be implanted subcutaneously in a "pacemaker-like" 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.

About CircuLite™

CircuLite is developing a miniature blood pump, designed to be placed superficially, for the long-term treatment of chronic heart failure. 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.

http://www.CircuLite.net