Sunshine Heart's German Erlangen Site Achieves First Implant for OPTIONS HF EU Post-Market Study

http://finance.yahoo.com/news/sunshine-hearts-german-erlangen-achieves-103000440.html


Sunshine Heart's German Erlangen Site Achieves First Implant for OPTIONS HF EU Post-Market Study
Sunshine Heart, Inc. 27 minutes ago GlobeNewswire

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EDEN PRAIRIE, Minn., Jan. 8, 2015 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (SSH) announced today that the Company's German Erlangen site for the OPTIONS-HF study has implanted its first patient with the C-Pulse(R) System for moderate to severe heart failure. Prof. Dr. Michael Weyand of the University Hospital of Erlangen performed the operation, which took place on November 19th, 2014. The surgical implantation procedure was successfully completed and the patient suffering from an ischemic cardiomyopathy was discharged from the hospital 8 days post-surgery.
"The study results showed improvement of heart failure symptoms without the patient requiring anticoagulation medication for the device. Furthermore, we preserve the option for a VAD implantation or heart transplant. Two weeks after discharge I called the patient and he felt well. In 6 weeks he'll be returning to the facility for his first check-up," commented Daniel Bujnoch, Resident of the Cardiac Surgery Department of the University Hospital of Erlangen.
This milestone marks the twelfth implantation of the CE marked C-Pulse System across fourteen activated EU centers participating in the OPTIONS HF post-market surveillance clinical study. Germany remains a key country as part of Sunshine Heart's overall European strategy for both the OPTIONS HF study and future commercialization plans.
"This achievement is a meaningful milestone for the Company as our expansion in Germany remains crucial for the completion of the OPTIONS HF study. As we begin a new year, I am pleased with the overall status of this post-market study and the U.S. COUNTER HF(TM) pivotal 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 study 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.