CircuLite has obtained CE mark approval for its new micro-blood pump, Synergy circulatory support system, designed to treat ambulatory heart failure patients.
By using a mini-thoracotomy, the system is surgically implanted and is placed in a pacemaker-like pocket under the right collarbone to deliver 4.25l of blood per minute and to reduce the heart’s workload, while improving blood flow to vital organs.
The CE mark approval was based on positive clinical results from 44 our of 59 patients multi-centre European trial, designed to demonstrate the safety and efficacy of Synergy system.
The results demonstrated improvements in hemodynamics, exercise capacity and overall quality of life, according to the company.
Gasthuisberg University Hospital cardiac surgery chief, professor and CircuLite clinical study principal investigator Dr Bart Meyns said Synergy iswell-suited for ambulatory heart failure patients due to its fast, minimally invasive procedure and small size.
"Patients typically recover from the procedure quickly and are soon after able to perform many activities that they could not do before," Meyns said.
"This technology allows me to provide a new treatment strategy for a large number of patients who previously had no definitive options."
CircuLite president and CEO Paul Southworth said Synergy works as a complement to the heart’s function to help patients not responding to standard medical management.
"The benefits are multifaceted — patients feel better, recover rapidly and are discharged quickly — which provides the potential for a cost reduction impact for hospitals," Southworth said.
"With CE Marking in place, we will begin a controlled launch of this groundbreaking advancement in select European markets."
Image: New micro-blood pump system delivers 4.25l of blood per minute and to reduce the heart’s workload in ambulatory heart failure patients. Photo: Courtesy of Business Wire.