The US Food and Drug Administration (FDA) has granted conditional approval to CircuLite to conduct an investigational device exemption (IDE) feasibility clinical study on its micro-blood pump, designed to reverse the symptoms of heart failure in ambulatory chronic heart failure patients.
The CE-marked Synergy Circulatory Support System, which the company claims to be the world's smallest circulatory support pump, is surgically implanted using a mini-thoracotomy, with the micro-pump placed in a pacemaker-like pocket.
Approximately the size and weight of an AA battery, the minimally-invasive device delivers 4.25l of blood per minute and reduces the heart's workload, while improving blood flow to vital organs, according to the company.
In addition, Synergy is intended to reduce rehospitalisations associated with heart failure symptoms as well as the surgical risks associated with cardiopulmonary bypass support.
The trial, safety evaluatIon of the CircuLite Synergy circulatory assist device in a non-inotrope dependent, ambulatory patient with end-stage chronic heart failure: a pilot study (IMPACT), will enrol 20 patients from seven US clinical sites to evaluate the use of the Synergy system for long-term support in ambulatory chronic heart failure patients (INTERMACS =4) who remain symptomatic despite optimal medical management.
During the company's European CE Mark clinical study, the device improved hemodynamics, exercise capacity and overall quality of life in ambulatory chronic heart failure patients (INTERMACS =4 or NYHA Class III/IV).
CircuLite chief executive officer Paul Southworth said; "Beginning our US feasibility trial marks a significant milestone for the company, and is the first step on our path to providing a new treatment option to tens of thousands of US ambulatory chronic heart failure patients who have no other options today."
The company said it is currently conducting a controlled commercial rollout in Europe.
Image: The new micro-blood pump system delivers 4.25l of blood per minute to reduce the heart's workload in ambulatory heart failure patients. Photo: Courtesy of Business Wire.