ZURICH–(BUSINESS WIRE)–Sequana Medical
announced that initial results from the PIONEER Clinical Study of its ALFApump
System were presented today at the 47th annual European Association for Study
of the Liver Meeting in Barcelona.
The data demonstrated that the ALFApump System is a safe and effective device
for management of ascites in patients with advanced cirrhosis. The PIONEER
study is a prospective, multi-centre, open label study of patients with refractory
ascites due to liver cirrhosis conducted at nine centres in four European
countries. Sequana Medicals ALFApump System is the first and only system for
the automatic and continual removal of ascites. Refractory ascites affects over
100,000 patients in Europe and the US every year and the number of
patients is growing at an annual rate of 10% due to the accelerating incidence
of hepatitis and obesity-related liver disease.
Dr. Jose Such, Chief of Hepatology at the Hospital General,
University de Alicante, Spain,
presented initial data in a session entitled “Description of an Automated
Low-Flow Ascites (ALFA) pump system for the treatment of ascites in patients
with cirrhosis. Preliminary Report”. In addition to safety and efficacy, the
data showed that the ALFApump System significantly reduced the median number of
paracentesis procedures from 3.4 in the month prior to pump implant to just 0.2
per month and there was a 91% reduction in the volume removed by paracentesis.
Ascites is a common complication among patients with
late-stage liver disease and is the leading reason for hospitalization among
patients with cirrhosis. Paracentesis, which involves inserting a large-bore
needle into the abdomen to drain 5-10 litres of accumulated ascites, is the
most common procedure for the treatment of ascites. However, paracentesis has
to be repeated frequently, often every 7-10 days, as it doesnt prevent the
re-accumulation of ascites. This repeated procedure is burdensome both to the
patient and healthcare service provider.
“The ALFApump System was developed to bring significant
benefits to both patients and physicians, and has the potential to become the
new standard of care for management of refractory ascites”, said Dr. Noel L.
Johnson, CEO of Sequana Medical. “I am quite pleased that the EASL Board
selected the abstract describing the initial data from the ALFApump Pioneer
Study for oral presentation at this years International Liver Congress.”
The ALFApump System consists of a subcutaneously implanted
battery-powered pump connected to a catheter placed in the abdominal cavity
which automatically and continually collects ascites and moves it to the
bladder, where it is eliminated from the patient through normal urination.
“I am delighted to have had the opportunity to present these
promising results from the Pioneer Study at the EASL congress”, stated Dr. Jose
Such. “The ALFApump System is proving to be a safe and efficacious device that
will improve the lives of thousands of patients with refractory ascites by
freeing them from the burden of repeat visits to the hospital for
The ALFApump System was granted CE Mark in 2011 and is
currently being introduced into leading hepatology centres across Europe.
About Sequana Medical:
Founded in 2006, Sequana Medical AG is a Swiss medical device company backed by
NeoMed Management, VI Partners, Biomed Invest, Capricorn Health Tech and
Entrepreneurs Fund, dedicated to improving patient lives through innovative
technologies to manage fluid overload in patients suffering from liver disease,
cancer and congestive heart failure.