Sequana Medical, a specialist in the treatment of fluid overload in liver disease, heart failure and cancer, has announced that it has implanted the 1,000th alfapump for the treatment of recurrent and refractory ascites due to liver cirrhosis and malignant ascites.
The Company also reports that it has received all administrative clearances to start the US MOJAVE study of DSR 2.0 in congestive heart failure patients and expects to enrol the first patient imminently.
Ian Crosbie, chief executive officer of Sequana Medical, commented: “We developed the alfapump to transform the lives of patients with recurrent and refractory ascites due to liver disease. For too long they have had to rely upon large volume paracentesis, a therapy developed by the ancient Egyptians and with little improvement in the last two thousand years. This important patient population is forecast to grow strongly due to the increasing prevalence of NASH/ fatty liver disease, one of the key health challenges in North America today. We believe that the data recently presented at the EASL Liver meeting demonstrates the potential for alfapump to transform patient lives – virtually eliminating needle paracentesis and delivering clinically important improvement in patient quality of life.
“We look forward to submit our Pre-Market Approval to the US FDA later this year and are preparing for commercial launch of the alfapump in North America through our own specialty salesforce.”
A 63-year old alfapump patient from Canada said: “The alfapump changed my life. I thought I was going to die. I got lucky with the alfapump, my daily routine is getting back, with no pain and suffering, just feeling good about taking care of myself. My approach to life totally changed since the alfapump. I look at it as a second chance in life.”
Sequana Medical’s alfapump is a fully implantable, wirelessly charged device that continuously collects ascites as it forms in the abdominal cavity and moves it into the bladder, where it is naturally passed from the body through urination. Since the first alfapump was implanted at the end of 2008, there has been a steady increase in the number of patients benefiting from the improved quality of life that the alfapump brings.