Profile: Sunshine Heart Inc (SSH.OQ)
Sunshine Heart, Inc., incorporated on August 22, 2002, is an early-stage medical device company focused on developing, manufacturing and commercializing its C-Pulse Heart Assist System for treatment of Class III and ambulatory Class IV heart failure. The C-Pulse Heart Assist System 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. As of December 31, 2013, the Company was in the process of obtaining regulatory approvals necessary to sell its system in the United States.
The Company has developed tools to allow the C-Pulse to be implanted through a small pacemaker-like incision between the patient’s ribs and sternum rather than a sternotomy. Patients implanted through its minimally invasive procedure require a hospital stay of four to seven days in connection with implantation of the C-Pulse System, after which they return home. During the year ended December 31, 2011, the Company completed enrollment and implantation of 20 patients in the North American feasibility phase of its trial. In April 2011, the Food and Drug Administration (FDA) approved an expansion protocol to allow the Company to implant up to 20 additional patients and add two additional centers to its feasibility study.
The Company competes with Thoratec Corporation, HeartWare International Inc., CardioKinetix, Inc., AbioMed, Inc., Jarvik Heart, Inc., MicroMed Technology, Inc., SynCardia Systems, Inc., Terumo Heart, Inc. and Berlin Heart GmbH.
Sunshine Heart Inc
12988 Valley View Rd
EDEN PRAIRIE MN 55344-3657