Sequana Medical, a Belgium-based medical device company, has announced the 1,000th implant of its alfapump device, which is used for the treatment of ascites. The company is now pivoting its focus towards the US MOJAVE study, which will investigate its direct sodium removal (DSR) therapy in patients with congestive heart failure.
The alfapump is an implantable device designed to collect fluid build-up in the abdomen and move it to the bladder, where it can be eliminated through urination. While the device has CE mark approval, Sequana Medical is seeking approval in North America and Canada. In June, the company reported positive results from its POSEIDON study, highlighting the device's safety and significant clinical improvements.
POSEIDON Study and FDA Submission
Sequana Medical intends to use the data from the pivotal North American POSEIDON trial (NCT03973866) to support its pre-market approval (PMA) application to the US Food and Drug Administration (FDA) later this year. According to Sequana Medical CEO Ian Crosbie, the data presented at the EASL Liver meeting demonstrated the potential of alfapump to transform patient lives by virtually eliminating the need for needle paracentesis and delivering clinically important improvements in patient quality of life. The company is preparing for the commercial launch of the alfapump in North America through its own specialty salesforce.
MOJAVE Study and DSR Therapy
Sequana Medical has also announced that it anticipates enrolling the first patient in its US MOJAVE study soon, following the FDA's granting of an investigational new drug (IND) application for its DSR therapy in May. This study will investigate the company's second-generation DSR therapy in patients with congestive heart failure, focusing on treating fluid overload, a common issue in these patients.
The DSR therapy aims to safely and effectively eliminate congestion, reduce repeated hospitalizations, and improve clinical outcomes for the estimated 200,000 diuretic-resistant congestive heart failure patients in the US. Data from the randomized, controlled Phase I/IIa study is expected by the end of 2023. Crosbie stated that the company believes its DSR therapy has the potential to be a disease-modifying heart failure therapy, based on strong safety and efficacy data reported from the RED DESERT and SAHARA proof-of-concept studies.
alfapump System Details
The alfapump system, which received CE mark approval in 2011, is also included in the EASL’s clinical practice guidelines for decompensated cirrhosis and the UK’s NICE interventional procedure guidance for cirrhosis-induced refractory ascites. The POSEIDON trial was a multi-center, prospective, single-arm, crossover pivotal study involving 70 patients with refractory or recurrent ascites implanted with the device after a three-month pre-implant observation phase with standard-of-care therapy. The primary outcomes included the number of draining procedures required pre- and post-implant and surgical reintervention due to adverse events. The trial took place across approximately 20 centers in the US and Canada.
