German Center in Sunshine Heart Trial Completes First Implantation of C-Pulse

Eden Prairie, Minn.-based Sunshine Heart Inc.’s German Erlangen site for the OPTIONS-HF study has implanted its first patient with the C-Pulse system for moderate to severe heart failure. Michael Weyand, M.D., of the University Hospital of Erlangen performed the operation. The surgical implantation procedure was successfully completed and the patient suffering from an ischemic cardiomyopathy was discharged from the hospital eight days post-surgery.

The C-Pulse Heart Assist system, or C-Pulse system, is an investigational device in the United States, Canada and countries that do not recognize the CE mark approval. It uses intra-aortic balloon counterpulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient’s current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices, artificial hearts or transplants. It may also provide relief from the symptoms of class III and ambulatory class IV heart failure and improve quality of life and cardiac function. Company officials reported that based on the feasibility study results, some patients treated with the system may be able to stop using the device due to sustained improvement in their conditions as a result of the therapy.

“The study results showed improvement of heart failure symptoms without the patient requiring anticoagulation medication for the device,” said Daniel Bujnoch, M.D., resident of the cardiac surgery department of the University Hospital of Erlangen. “Furthermore, we preserve the option for a VAD (vascular assist device) implantation or heart transplant. Two weeks after discharge I called the patient and he felt well. In six weeks he’ll be returning to the facility for his first check-up.”

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 in Sunshine Heart’s overall European strategy for both the 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,” said CEO Dave Rosa. “As we begin a new year, I am pleased with the overall status of this post-market study and the U.S. COUNTER-HF pivotal study.”

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.