CircuLite has obtained conditional approval from the US Food and Drug Administration (FDA) for its Synergy Circulatory Support System, designed for reversing the symptoms of heart failure in ambulatory chronic heart failure patients.
The CE-marked minimally-invasive micro-blood pump device, which the company claims to be the world's smallest circulatory support pump, is surgically implanted using a mini-thoracotomy and the micro-pump is placed in a pacemaker-like pocket.
The device is approximately the size and weight of an AA battery and delivers 4.25l of blood per minute and reduces the heart's workload, while improving blood flow to vital organs, claims the company.
With the approval, the company said it is initiating a 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) trial.
The study, which will enroll 20-patient from seven US clinical sites, is designed 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).
The company said it is currently conducting a controlled commercial rollout in Europe.