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
"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
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."
SOURCE NovaShunt AG