<?xml version="1.0" encoding="UTF-8"?>
<!--Generated by Squarespace V5 Site Server v5.13.159 (http://www.squarespace.com) on Sat, 25 May 2013 18:55:45 GMT--><feed xmlns="http://www.w3.org/2005/Atom" xmlns:dc="http://purl.org/dc/elements/1.1/"><title>Press Releases</title><subtitle>Press Releases</subtitle><id>http://www.sunshineheart.com/press-releases/</id><link rel="alternate" type="application/xhtml+xml" href="http://www.sunshineheart.com/press-releases/"/><link rel="self" type="application/atom+xml" href="http://www.sunshineheart.com/press-releases/atom.xml"/><updated>2013-05-10T15:58:41Z</updated><generator uri="http://five.squarespace.com/" version="Squarespace V5 Site Server v5.13.159 (http://www.squarespace.com)">Squarespace</generator><entry><title>First Patient Implanted in C-Pulse System European Post-Market Study</title><id>http://www.sunshineheart.com/press-releases/first-patient-implanted-in-c-pulse-system-european-post-mark.html</id><link rel="alternate" type="text/html" href="http://www.sunshineheart.com/press-releases/first-patient-implanted-in-c-pulse-system-european-post-mark.html"/><author><name>Sunshine Heart</name></author><published>2013-05-10T15:56:20Z</published><updated>2013-05-10T15:56:20Z</updated><summary type="html" xml:lang="en-US"><![CDATA[The implant of the first patient in the OPTIONS HF C-Pulse System Multicenter Study. The post market study is intended to treat patients with moderate to severe heart failure.]]></summary></entry><entry><title>Sunshine Heart Receives Unconditional FDA Approval for C-Pulse® System‘s U.S. Pivotal Trial</title><id>http://www.sunshineheart.com/press-releases/sunshine-heart-receives-unconditional-fda-approval-for-c-pul.html</id><link rel="alternate" type="text/html" href="http://www.sunshineheart.com/press-releases/sunshine-heart-receives-unconditional-fda-approval-for-c-pul.html"/><author><name>Sunshine Heart</name></author><published>2012-11-21T06:27:21Z</published><updated>2012-11-21T06:27:21Z</updated><summary type="html" xml:lang="en-US"><![CDATA[Sunshine Heart, Inc. (NASDAQ: SSH; ASX: SHC), a global medical device company focused on innovative technologies for moderate to severe heart failure, today announced it has received unconditional approval from the FDA to commence its pivotal U.S. trial for its flagship C-Pulse® Heart Assist System]]></summary></entry><entry><title>Sunshine Heart Receives 2012 Frost &amp; Sullivan North American Heart Failure Treatment New Product Innovation Award for C-Pulse®</title><id>http://www.sunshineheart.com/press-releases/sunshine-heart-receives-2012-frost-sullivan-north-american-h.html</id><link rel="alternate" type="text/html" href="http://www.sunshineheart.com/press-releases/sunshine-heart-receives-2012-frost-sullivan-north-american-h.html"/><author><name>Sunshine Heart</name></author><published>2012-10-23T15:39:42Z</published><updated>2012-10-23T15:39:42Z</updated><summary type="html" xml:lang="en-US"><![CDATA[Sunshine Heart has received the 2012 North American Heart Failure Treatment New Product Innovation Award. This award highlights the innovation and potential value of Sunshine Heart’s flagship C-Pulse® Heart Assist System.]]></summary></entry><entry><title>Sunshine Heart’s Feasibility Study Data to Be Presented at 2012 Transcatheter Cardiovascular Therapeutics Conference</title><id>http://www.sunshineheart.com/press-releases/sunshine-hearts-feasibility-study-data-to-be-presented-at-20.html</id><link rel="alternate" type="text/html" href="http://www.sunshineheart.com/press-releases/sunshine-hearts-feasibility-study-data-to-be-presented-at-20.html"/><author><name>Sunshine Heart</name></author><published>2012-10-19T15:25:58Z</published><updated>2012-10-19T15:25:58Z</updated><summary type="html" xml:lang="en-US"><![CDATA[Sunshine Heart, Inc. (NASDAQ:SSH;  ASX:SHC), a global medical device company focused on innovative technologies for moderate heart failure, today announced that its flagship C-Pulse Heart Assist System will be featured in two clinical presentations at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. The TCT symposium will take place October 22nd through 26th in Miami, Florida]]></summary></entry><entry><title>Sunshine Heart Announces Conditional Approval of IDE from the FDA for C-Pulse® Heart Assist System</title><id>http://www.sunshineheart.com/press-releases/sunshine-heart-announces-conditional-approval-of-ide-from-th.html</id><link rel="alternate" type="text/html" href="http://www.sunshineheart.com/press-releases/sunshine-heart-announces-conditional-approval-of-ide-from-th.html"/><author><name>Sunshine Heart</name></author><published>2012-10-01T15:25:28Z</published><updated>2012-10-01T15:25:28Z</updated><summary type="html" xml:lang="en-US"><![CDATA[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 it has received conditional approval from the FDA for an Investigational Device Exemption (IDE) for its flagship C-Pulse® Heart Assist System.
“We are thrilled to receive conditional approval from the FDA to move forward into a pivotal trial for C-Pulse,” said Dave Rosa, CEO of Sunshine Heart. “Today’s announcement represents another significant milestone for the Company, as well as for the C-Pulse System. I am especially pleased that we were able to receive this approval on our initial submission. The Company has achieved its regulatory and clinical objectives by receiving both the CE Mark and U.S. IDE approval this year. These timely approvals continue to support the Company’s market guidance and timelines.”]]></summary></entry><entry><title>Sunshine Heart Announces Conditional Approval from FDA for Its Next Generation C-Pulse® System Driver</title><id>http://www.sunshineheart.com/press-releases/sunshine-heart-announces-conditional-approval-from-fda-for-i.html</id><link rel="alternate" type="text/html" href="http://www.sunshineheart.com/press-releases/sunshine-heart-announces-conditional-approval-from-fda-for-i.html"/><author><name>Sunshine Heart</name></author><published>2012-08-06T21:03:27Z</published><updated>2012-08-06T21:03:27Z</updated><summary type="html" xml:lang="en-US"><![CDATA[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.]]></summary></entry><entry><title>Sunshine Heart Announces CE Mark for C-Pulse® Heart Assist System</title><id>http://www.sunshineheart.com/press-releases/sunshine-heart-announces-ce-mark-for-c-pulse-heart-assist-sy.html</id><link rel="alternate" type="text/html" href="http://www.sunshineheart.com/press-releases/sunshine-heart-announces-ce-mark-for-c-pulse-heart-assist-sy.html"/><author><name>Sunshine Heart</name></author><published>2012-07-25T16:19:05Z</published><updated>2012-07-25T16:19:05Z</updated><summary type="html" xml:lang="en-US"><![CDATA[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.]]></summary></entry><entry><title>Sunshine Heart Announces First Patient Reaches Two-Year Follow-up Mark for C-Pulse® Heart Assist System</title><id>http://www.sunshineheart.com/press-releases/sunshine-heart-announces-first-patient-reaches-two-year-foll.html</id><link rel="alternate" type="text/html" href="http://www.sunshineheart.com/press-releases/sunshine-heart-announces-first-patient-reaches-two-year-foll.html"/><author><name>Sunshine Heart</name></author><published>2012-07-24T22:56:59Z</published><updated>2012-07-24T22:56:59Z</updated><summary type="html" xml:lang="en-US"><![CDATA[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.]]></summary></entry><entry><title>Sunshine Heart Receives Health Canada Approval to Modify its Ongoing Investigational Study to Use the Next Generation C-Pulse® System Driver</title><id>http://www.sunshineheart.com/press-releases/sunshine-heart-receives-health-canada-approval-to-modify-its.html</id><link rel="alternate" type="text/html" href="http://www.sunshineheart.com/press-releases/sunshine-heart-receives-health-canada-approval-to-modify-its.html"/><author><name>Sunshine Heart</name></author><published>2012-06-07T21:49:49Z</published><updated>2012-06-07T21:49:49Z</updated><summary type="html" xml:lang="en-US"><![CDATA[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.]]></summary></entry><entry><title>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</title><id>http://www.sunshineheart.com/press-releases/single-center-data-from-c-pulse-feasibility-trial-in-patient.html</id><link rel="alternate" type="text/html" href="http://www.sunshineheart.com/press-releases/single-center-data-from-c-pulse-feasibility-trial-in-patient.html"/><author><name>Sunshine Heart</name></author><published>2012-05-31T15:28:44Z</published><updated>2012-05-31T15:28:44Z</updated><summary type="html" xml:lang="en-US"><![CDATA[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.]]></summary></entry></feed>