The Ghent, Belgium-based company’s pump treats these fluid overload conditions that arise due to liver cirrhosis and malignant ascites.
In addition to the milestone implant, Sequana said it received all administrative clearances to begin its U.S. MOJAVE study. This study evaluates its DSR 2.0 fluid overload pump therapy in congestive heart failure patients. The company expects to enroll the first patient imminently, according to a news release.
Sequana plans to submit Alfapump to the FDA for premarket approval later this year. It also has preparations underway for a North American commercial launch through its own specialty salesforce.
“We developed the Alfapump to transform the lives of patients with recurrent and refractory ascites due to liver disease,” said Ian Crosbie, Sequana Medical CEO. “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.”
More about the Sequana Medical Alfapump
Alfapump, a fully implantable, wirelessly charged device, continuously collects ascites as it forms in the abdominal cavity. It moves it into the bladder, where it naturally passes from the body through urination.
The first Alfapump implant took place at the end of 2008. Sequana says more than 100,000 liters of ascites have been removed safely with the system.
Clinical data demonstrated effectiveness in the control of ascites, virtually eliminating the need for large-volume paracentesis. Safety fell in line with expectations, with six pumps explanted. Three explants took place due to skin erosion and Sequana attributed the other three to moderate bladder discomfort.
The company reported a similar number of major adverse events and a comparable number of serious infections in the pre- and post-implant period. Sequana also observed stable kidney function over long-term follow-up.
Alfapump produced clinically meaningful and statistically significant improvements in quality of life at six months post-implantation. One-year survival probability totaled 70%. That compared favorably to literature citing a survival rate of 50% at one year in this patient population.
