Sequana Medical Receives CE-Mark Approval for the use of its alfapump® System in Cancer Patients With Malignant ascites
ZÃœRICH, Switzerland, October 30, 2012 /PRNewswire/ –
Sequana Medical is pleased to announce that it has received CE mark approval for use
of its alfapump(R) system in patients with ascites caused by cancer (malignant ascites).
The alfapump(R) system was first introduced to the European market last year for patients
with refractory ascites caused by advanced liver disease. The system is fully implantable,
and automatically and continually collects ascites from the abdominal cavity and moves it
to the bladder, where it is excreted naturally from the body.
Malignant ascites is an excess build-up of fluid in the abdominal cavity and is a
common complication among patients with ovarian, pancreatic and gastric cancer. It is
usually managed with large-volume paracentesis, an invasive hospital-based procedure in
which the ascites is drained over a number of hours through a large-bore needle inserted
in the abdomen.
“CE mark approval of the alfapump(R) system for patients with malignant ascites is a
major milestone for Sequana Medical”, stated Noel L. Johnson, President and CEO of Sequana
Medical. “Malignant ascites affects more than 20,000 people per year in the EU. Our system
was designed to improve quality of life, so we are very pleased indeed that cancer
patients with ascites will now also be able to benefit from our technology.”
Patients no longer experience the discomfort of chronic ascites accumulation and they
no longer have to make regular trips to the hospital for paracentesis. By decreasing
hospitalization time, the alfapump(R) system reduces the burden of ascites for patients,
physicians and the healthcare system.
“This is an exciting development. The alfapump(R) system hopes to provide malignant
ascites patients with a much-needed new treatment option,” commented Professor Hani Gabra,
Professor of Medical Oncology at Imperial College London. “Furthermore, there is enormous
potential for this technology in the field of personalized medicine. Ascites can be easily
collected via urine sample and then analyzed to determine the presence of certain
biomarkers. We are evaluating such urine derived tumour cells and this will allow the
physician to quickly identify changes in the disease state and tailor patient treatment
accordingly, with a view to improving outcomes”.
Sequana Medical’s PIONEER study, a 40-patient non-randomized trial which concluded in
2011, clearly demonstrated the safety and performance of the alfapump(R) system and
demonstrated a significant reduction in the requirement for paracentesis. Several
follow-up studies are currently in the pipeline, including AMAZE, a 50-patient randomized
controlled trial in ovarian cancer patients suffering from ascites. This trial be will be
led by Professor Gabra of Imperial College London. ENDS
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 Entrepreneur’s Fund,
dedicated to improving patient lives through innovative technologies to manage fluid
overload in patients suffering from liver disease, cancer and congestive heart failure.
Contact: Sequana Medical Emily Woodward Marketing Manager Emily.firstname.lastname@example.org Tel: +41-44-403-55-21
SOURCE Sequana Medical AG