C-Pulse®Clinical TrialSunshine Heart , Inc. is sponsoring a prospective, multi–center feasibility trial to assess the safety and provide indications for performance of the Sunshine Heart C–Pulse System ("C-Pulse"). The purpose of the study is to determine whether use of C–Pulse as treatment for patients in moderate to severe heart failure (HF) is associated with reasonable assurance of safety and performance, such that the C–Pulse merits Food and Drug Administration (FDA) approval for continuation into a pivotal study to examine the safety and efficacy of C-Pulse for U.S. market approval. Full study details of the C-Pulse clinical trial are available at clinicaltrials.gov or download a list of our Clinical Trial Locations. |