NovaShunt Starts Its Pivotal Clinical Study PIONEER To Demonstrate The Clinical Value Of The AFS System
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NovaShunt 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 and continuously removes excess fluid known as ascites that builds up in the abdominal cavity in patients with liver disease and other conditions.
"This is a milestone in our company history," said Noel Johnson, CEO and co-founder of NovaShunt, "and we strongly believe that this trial will both provide important clinical information and also demonstrate the benefit of continuous removal of ascites by the AFS-System in patients suffering from refractory ascites due to liver disease and other conditions."
Excess fluid build-up, which is known as ascites, in the abdominal cavity is a common complication among patients with late-stage liver disease, congestive heart failure (CHF) and certain cancers. Ascites affects more than a million patients in the EU and US. The majority of patients with ascites can be managed with a sodium-restricted diet and increasingly larger doses of diuretics. However, more than 10% of the patients develop refractory ascites and become non-responsive to diuretic therapy.
"Based on our pre-clinical research and our feasibility study results, the AFS System showed a significant reduction of paracentesis procedures and in the use of diuretics," said Dr. Pedro Eerdmans, Chief Medical Officer of the company. "We've seen some important clinical improvements in the feasibility study patients we enrolled in 2009. The AFS System decreased the overall need for paracentesis by more than 90% in our study group and one patient is fast approaching the one-year anniversary of his implant."
About the Automated Fluid Shunt (AFS) System
NovaShunt's innovative core technology is the Automated Fluid Shunt (AFS) System. The AFS System consists of a subcutaneously implanted battery-powered pump with a catheter placed in the abdominal cavity and another catheter connected to the bladder. The AFS System automatically and continuously collects fluid as it forms in the abdominal cavity and moves it to the bladder, where it is naturally passed from the body. The patient can wirelessly recharge the battery through the skin, using a simple charger. This charger also collects pump and patient data which can be easily downloaded to a computer and reviewed by the patient's physician.
The number of people with ascites will grow substantially over the next decade due to accelerating incidence of hepatitis and obesity-related liver disease (NAFLD). The current standard treatment for these patients is called 'paracentesis', a procedure in which a large bore needle is inserted into the patient's abdomen, sometimes weekly or bi-weekly, to remove between 5-10 liters of accumulated ascites. The cumulative cost of repeat paracentesis for these patients often exceeds EUR25,000 each year.
NovaShunt is a privately owned Swiss medical device company that is dedicated to improving patient lives through the development, manufacture and commercialization of automated implantable pump systems to manage fluid balance within the body. NovaShunt is focused on areas of unmet clinical need where its products can significantly improve clinical outcomes, reduce health care costs and improve patient quality of life.
"For a long time now I have been feeling much better. I have not had any paracentesis procedures since the implant and need much less, sometimes even no diuretics. In summer I went on vacation where I enjoyed swimming and the Mediterranean Cuisine. I'm active every day and I enjoy my new life."
Source: NovaShunt AG
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