Sunshine Heart, a provider of a devices and technologies for moderate to severe heart failure patients, has completed the animal study of transcutaneous C-Pulse Heart Assist System.
The study, conducted at Texas Heart Institute in Houston, demonstrated that a combined driver and C-Pulse cuff implanted around the heart’s aorta can be successfully powered from a wireless, external battery unit.
The C-Pulse system is an investigational device designed to relieve the symptoms of heart failure, such as shortness of breath and reduced mobility, through the use of counter-pulsation technology.
The C-Pulse Heart Assist System recently completed enrollment of 20 patients in its US Food and Drug Administration (FDA)-approved investigational device exemption (IDE) feasibility study.
The study was primarily designed to assess safety and provide indications of performance of this device in moderate to severe heart failure patients who suffer from symptoms such as shortness of breath and reduced mobility.
Once the six-month follow-up with the 20th patient is completed, Sunshine Heart will submit the feasibility data to the FDA.
Sunshine Heart CEO Dave Rosa said while the company’s primary focus is to initiate a pivotal trial using a new single unit system planned for release later in the year, their R&D team will continue to study and refine the specifications of the fully-implantable C-Pulse system.
"Our goal is to ultimately develop a fully-implantable device that can connect directly to a patient’s pacemaker," Rosa said.
Â