Sunshine Heart Announces Conditional Approval from FDA for Its Next Generation C-Pulse® System Driver

Sunshine Heart, Inc. (NASDAQ: SSH /ASX: SHC) announced today that it has received conditional approval from the United States Food and Drug Administration (FDA) for its next generation C-Pulse System driver. This new iteration is designed to provide moderate to severe heart failure patients with enhanced patient comfort and performance. The new driver features a single unit which is lighter, quieter and approximately half the size of its predecessor and also features a number of software enhancements.

Click to read more ...

Sunshine Heart Announces CE Mark for C-Pulse® Heart Assist System

Sunshine Heart announced today that it has received CE Mark approval for its C-Pulse Heart Assist System for the treatment of Class III and ambulatory Class IV heart failure. This will allow for commercialization of the technology in Europe and countries in Asia and Latin America that recognize the CE Mark. The Class III heart failure population is estimated at 3.7 million patients in the European Union, and currently, there are limited, and often, unsuccessful treatment options for this patient population.

Click to read more ...

Sunshine Heart Announces First Patient Reaches Two-Year Follow-up Mark for C-Pulse® Heart Assist System

Sunshine Heart announced today that two-year follow-up was completed for a patient that was implanted with the C-Pulse Heart Assist System in the North America feasibility trial which completed enrollment in June 2011. This was the first patient to reach two-year follow-up in the trial.

Click to read more ...

Sunshine Heart Receives Health Canada Approval to Modify its Ongoing Investigational Study to Use the Next Generation C-Pulse® System Driver

Sydney, Australia and Eden Prairie, MN: June 7, 2012: Sunshine Heart, Inc. (NASDAQ: SSH / ASX: SHC), a global medical device company focused on innovative technologies for moderate to severe heart failure, today announced that the company has been granted approval by Health Canada to use its next generation C-Pulse® Heart Assist System driver in ongoing clinical studies at Royal Victoria Hospital. The new C-Pulse driver is designed to provide heart failure patients with enhanced patient comfort and performance. The C-Pulse System is a new investigational therapeutic approach based on proven balloon counter-pulsation technology for the treatment of patients with Class III and ambulatory Class IV heart failure.

Click to read more ...

Single Center Data from C-Pulse® Feasibility Trial in Patients with Moderate to Severe Heart Failure to be Presented at the 2012 ISMICS Annual Meeting

May 31, 2012: Sunshine Heart, Inc. (NASDAQ: SSH / ASX: SHC), a global medical device company focused on innovative technologies for moderate to severe heart failure, today announced data from a single center participating in the U.S. Food and Drug Association (FDA) feasibility clinical trial for the C-Pulse® Heart Assist System will be presented at the 2012 International Society of Minimally Invasive Cardiothoracic Surgery (ISMICS) Annual Meeting in Los Angeles, May 30-June 2, 2012. Findings from a single center utilizing the C-Pulse System demonstrated that the device can be safely implanted utilizing a minimally invasive approach. The C-Pulse System is a new investigational therapeutic approach based on proven balloon counter-pulsation technology for the treatment of patients with Class III and ambulatory Class IV heart failure.

Click to read more ...