Austria has implanted its first patient, page-2

(RTTNews.com) - Sunshine Heart, Inc. (SHC.AX, SSH) said its initial Austrian site for the OPTIONS-HF study has implanted its first patient with the C-Pulse System for moderate to severe heart failure.
Prof. Dr. Herwig Antretter of the University of Innsbruck performed the operation, which took place on November 11.
A 92-minute surgical implantation procedure was successfully completed and the patient was discharged from the hospital 7 days after surgery.
The patient suffers from dilated cardiomyopathy with severe impairment of his left ventricle, low ejection fraction and has survived an extensive cardiopulmonary resuscitation due to sudden cardiac arrest in January without any neurological deficit.
Despite his advanced age and his medical history, the patient remains highly active and employed.
Sunshine said this milestone marks the eleventh implantation of the C-Pulse System across fourteen activated EU centers participating in the OPTIONS HF post-market surveillance clinical study.

Austrian Site Achieves First Implant

EDEN PRAIRIE, Minn., Dec. 1, 2014 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (Nasdaq:SSH) announced today that the Company's initial Austrian site for the OPTIONS-HF study has implanted its first patient with the C-Pulse System for moderate to severe heart failure. Prof. Dr. Herwig Antretter of the University of Innsbruck performed the operation, which took place on November 11th, 2014. A 92 minute surgical implantation procedure was successfully completed and the patient was discharged from the hospital 7 days post-surgery. This milestone marks the eleventh implantation of the C-Pulse System across fourteen activated EU centers participating in the OPTIONS HF post-market surveillance clinical study.
"The C-pulse system is an ideal addition for patients in the treatment of NYHA III and ambulatory IV stage heart failure," said Prof. Dr. Antretter. "It is easy to implant the device, doesn´t need a heart lung machine, and allows for quick patient recovery. Our patient was extubated in the operating room, stayed just a couple of hours in the ICU, and was then transferred to a normal ward. We discharged him after only one week."
The patient was selected in cooperation with Univ.-Doz. Dr. Gerhard Poelzl, F.E.S.C. a leading Heart Failure Cardiologist (department of Univ. Prof. Wolfgang-M. Franz, Internal Medicine III, Cardiology and Angiology) in the University Hospital of Innsbruck. The patient suffers from dilated cardiomyopathy with severe impairment of his left ventricle, low ejection fraction (EF < 25%) and has survived an extensive cardiopulmonary resuscitation due to sudden cardiac arrest in January 2014 without any neurological deficit. Despite his advanced age and his medical history, the patient remains highly active and employed.
"I'm extremely pleased that we have introduced the C-Pulse therapy to yet another key country. As discussed in our Q3 quarterly update, we continue to remain enthusiastic regarding the increased overall momentum for the OPTIONS HF study," commented Dave Rosa, Sunshine Heart Inc. Chief Executive Officer.
The OPTIONS HF study is a post-market, multi-center, prospective, open label study that will include 50 patients in up to 15 European centers. The study is designed to observe clinical outcomes of heart failure patients treated with the C-Pulse system. The primary endpoint is comparable to the COUNTER HF trial as it evaluates the rate of re-hospitalization due to worsening heart failure and heart failure related death in addition to many other traditional heart failure endpoints.

Read more: http://www.nasdaq.com/press-release/sunshine-heart-provides-update-on-options-hf-eu-postmarket-study-20141201-00100#ixzz3KfvsGquc​

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