Sunshine Heart has completed two-year follow-up mark for first patient who was implanted with the C-Pulse Heart Assist System in the North America feasibility trial.
According to the results from the first patient, it was observed that the patient experienced a good recovery of function from the previous condition using the C-Pulse system.
The investigational device utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries.
St. Luke’s Hospital in Kansas City heart failure cardiologist Dr. Andrew Kao said the first patient could not walk or even say a few words without extreme perspiration and shortness of breath when Kao met him for the first time.
"After C-Pulse implantation, he can do many more activities — he can walk around comfortably and also has improved self-confidence," Kao said.
The company has also released the 12-month extended follow-up efficacy and safety data for the Feasibility Study of its C-Pulse Heart Assist System.
The study’s 6-month preliminary of 20 patients suggested positive efficacy trends for C-Pulse with statistically significant results in NYHA Class Reduction and Minnesota Living with Heart Failure (MLWHF) Quality of Life, respectively.
Under the study, two patients were disconnected permanently based on their level of improvement on the device.
With the support of the C-Pulse, no neurological events or strokes occurred in subjects at both 6 and 12 months.
Sunshine Heart CEO Dave Rosa said the company saw improvements in several efficacy endpoints without additional patients experiencing exit site infections over the 12-month follow-up period.
"We are also proud of reaching a two-year milestone for the technology and are equally pleased to hear how the technology is positively impacting patient’s lives," Rosa added.