Sunshine Heart Inc (SSH.OQ) Key Developments |
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Sunshine Heart Inc (SSH.OQ)

SSH.OQ on NASDAQ Stock Exchange Capital Market

30 Jun 2016
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Latest Key Developments (Source: Significant Developments)

Sunshine Heart, Inc announces the appointment of John Erb as Its Chief Executive Officer
Wednesday, 2 Mar 2016 04:15pm EST 

Sunshine Heart, Inc:Appointment of John Erb as its fulltime Chief Executive Officer (CEO) and President, effective immediately.Erb assumes the role of CEO following three months as interim-CEO and President and will remain Chairman of the Board of Directors.  Full Article

Sunshine Heart, Inc announces departure of its CEO
Monday, 30 Nov 2015 04:15pm EST 

Sunshine Heart, Inc:Announces departure of its chief executive officer david a. rosa.John L. Erb, Chairman of the board of directors of Sunshine Heart has been named interim chief executive officer.Chief Executive Officer David A. Rosa is leaving the company.  Full Article

Sunshine Heart Inc announces FDA approval to resume enrollment in counter hf US pivotal study for c-pulse heart assist system
Tuesday, 26 May 2015 05:30am EDT 

Sunshine Heart Inc:Says US Food and Drug Administration (FDA) has approved the resumption of patient enrollment in its COUNTER HF US pivotal study for the C-Pulse Heart Assist System.Says it has already begun the process to provide all pivotal study centers with the information required for their Investigational Review Board to approve the continuation of study enrollment.  Full Article

Sunshine Heart Inc provides update on U.S. Pivotal Study of C-Pulse Heart Assist System
Thursday, 16 Apr 2015 04:54pm EDT 

Sunshine Heart Inc:Announces that the U.S. Food and Drug Administration (FDA) has reviewed the Company's submission regarding the COUNTER HF's U.S. pivotal study pause and requested minor protocol changes be submitted in order to receive approval to resume patient enrollment.FDA did not indicate concerns regarding safety of the device.Says the Data Safety Monitoring Board (DSMB), reviewed COUNTER HF's data and recommended continuing the Study.FDA has reviewed the company's submission regarding the counter HF'S U.S. pivotal study pause.All four of reported patient deaths have been adjudicated by independent clinical events committee as being non-device related.  Full Article

Sunshine Heart, Inc receives FDA approval for interim analysis of U.S pivotal trial of C-Pulse(R) heart assist system
Wednesday, 25 Feb 2015 05:30am EST 

Sunshine Heart, Inc:Receives unconditional approval from FDA to conduct an interim analysis of Counter HF, it's U.S. pivotal study.Says Counter HF study is prospective, randomized, multi-center, controlled study that evaluates safety and efficacy of C-Pulse system for treatment of NYHA Class III and ambulatory Class IV heart failure.Integral to Counter HF study is assessment of C-Pulse's balloon counterpulsation treatment designed to improve heart function and reduce re-hospitalizations due to worsening heart failure.Purpose of study is to determine whether the C-Pulse System is a safe and effective treatment for heart failure patients who meet key study qualifications.  Full Article

Sunshine Heart appoints Claudia Drayton as Chief Financial Officer
Monday, 5 Jan 2015 05:30am EST 

Sunshine Heart Inc:Appoints Claudia Drayton as its Chief Financial Officer.Says Drayton, who was formerly Chief Financial Officer and Senior Finance Director for Medtronic Inc.'s Integrated Health Solutions Business, replaces Jeff Mathiesen, who will provide consulting services to the Company through the first half of 2015.  Full Article