Sunshine Heart has announced that the first patient has completed a two-year follow-up mark for the C-Pulse Heart Assist System in the North America feasibility trial.
The company released the 12-month extended follow-up efficacy and safety data for the feasibility study, which reported positive trends in efficacy with continued improvements in NYHA class reduction, MLWHF quality of life score and six minute hall walk.
Dr. Andrew Kao, Saint Luke's Hospital (Kansas) heart failure cardiologist, 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 added.
The six-month preliminary data of 20 patients suggested positive efficacy trends for C-Pulse with statistically significant results in NYHA class reduction and Minnesota Living with Heart Failure quality of life, respectively.
The company believed that due to its non-blood contacting feature, no neurological events or strokes occurred in subjects supported with the C-Pulse at both six and 12 months.
Dave Rosa, Sunshine Heart CEO, said the company observed improvements in several efficacy endpoints without additional patients experiencing exit site infections during the 12-month follow-up period.
"We believe our preliminary results continue to illustrate that C-Pulse has the potential to improve the longevity and quality of life for moderate to severe heart failure patients," Rosa added.
The investigational device leverages 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.