In a European feasibility trial, CircuLite announced with the successful implantation of the first patient of its Synergy Pocket Circulatory Assist Device. A video demo of the device is available at the company’s website.
Pumping up to 3 liters of blood per minute, this is a miniature implantable blood pump, the size of an AA battery. It is implanted superficially in a pocket, like a pacemaker.
The device is intended to provide long-term, partial circulatory support in patients with chronic heart failure. The aim of the trial is to assess the safety of the device in patients with chronic heart failure who are waiting to receive heart transplants.
This isn’t something you’d want to use on a longterm basis, though. The device is powered by a six pound battery pack worn on an external belt. It also needs to be recharged every 8-12 hours, so users need to keep a close eye on battery levels.
“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 CircuLites 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.”
More than two million chronic heart failure patients worldwide continue to be symptomatic despite appropriate, optimal medical and device-based therapies. Feasibility studies will investigate hemodynamic and clinical effects of the Synergy device in patients awaiting heart transplants.
CircuLites 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.
11 Years of Engineering Effort
Paul Southworth, President and CEO of CircuLite, said
“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 key element 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 worlds 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 hearts 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.