August 8, 2007 - CircuLite Inc. reported the launch of the 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 in Leuven, Belgium, performed the first implant.
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.
For more information: www.CircuLite.net