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NovaShunt Starts its Pivotal Clinical Study "PIONEER" to Demonstrate the Clinical Value of the AFS System
Date:2/11/2010

ZUG, Switzerland, February 11 /PRNewswire/ -- NovaShunt today announced the initiation of its pivotal multi- center clinical study named PIONEER, a Prospective, multi-center, open label, non-randomized study to Investigate the safety and perfOrmance of the Automated Fluid ShuNt in patiEnts with ascitEs and diuretic Resistance.

The study is designed to evaluate the safety and performance of the Automated Fluid Shunt (AFS) System in replacing the need for paracentesis, the standard therapy for patients with refractory ascites. Secondary parameters in the study are concomitant reduction in the need for medication, health care costs (hospitals stays, treatment) and patients' quality of life. Data from the PIONEER study will be submitted to the Notified body to obtain CE Marking which will allow NovaShunt to enter the European market. The study is being led by the Principal Investigator Dr. Jose Such, Head of Hepatology, University General Hospital, Alicante, Spain, and will be initialized in five university hospitals in Europe specialized in managing patients with refractory ascites (located in Alicante, Barcelona, Frankfurt, Regensburg and London).

"We are very excited to begin the clinical evaluation of a novel technology for the treatment of patients with refractory ascites," said Dr. Such, Head of Hepatology, University General Hospital, Alicante, Spain. "As there are many patients in our clinic suffering from decompensated cirrhosis and the presence of ascites, the AFS System could be of great benefit for these people."

The AFS System is an implantable, battery powered pump that automatically
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SOURCE NovaShunt AG
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