Sunshine Heart, Inc. (NASDAQ: SSH, ASX: SHC) today announced that the Center for Devices and Radiological Health(CDRH) of the United States Food and Drug Administration(FDA) completed its review of Sunshine Heart’s Investigation Device Exemption(IDE) for the C-Pulse Heart Assist System feasibility trial. The FDA notified the Company that it has met the requirements of FDA regulation 21CFR 812.150(b)(5) and that no other information is required at this time.
Press Releases & News
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Sunshine Heart Announces Results of its C-Pulse® Feasibility Trial at the Transcatheter Cardiovascular Therapeutics Conference
Patients implanted with the C-Pulse Heart Assist System demonstrated statistically significant improvement based on New York Heart Association class reduction, Quality of Life and Left Ventricular
Sunshine Heart’s Feasibility Trial Outcomes to Be Presented at Transcatheter Cardiovascular Therapeutics Conference
October 19, 2011: Sunshine Heart, Inc. (ASX: SHC), a global medical device company focused on innovative technologies for moderate to severe heart failure, today announced that the C-Pulse Heart Assist System will be featured in two clinical presentations at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. The TCT symposium, sponsored by the Cardiovascular Research Foundation, will take place November 7 through 11 in San Francisco, California.
Sunshine Heart, Inc., a global medical device company focused on innovative technologies for Class III/ambulatory Class IV (moderate to severe) heart failure, today announced it has completed an initial animal study of a next-generation transcutaneous C-Pulse® Heart Assist System. The study, conducted at Texas Heart Institute in Houston, demonstrated that a combined driver and C-Pulse cuff implanted around the heart’s aorta can be successfully powered from a wireless, external battery unit. This fully-implantable C-Pulse model would eliminate the need for wires to breach the skin, thereby improving patient comfort and reducing the risk of infection.