Tag Archive for: fluid overload

Sequana Medical Announces US FDA Approval of alfapump® for the Treatment of Recurrent or Refractory Ascites due to Liver Cirrhosis

alfapump® is the first US approved active implantable medical device (Class III) for the treatment of recurrent or refractory ascites due to liver cirrhosis PMA Approval and FDA Breakthrough Device Designation US market opportunity estimated at over $2 billion in 2025, growing at 9%[1] due to MASH/NASH[2] and alcoholic liver disease US commercial launch planned for H2 2025 […]

Sequana Medical announces first patient enrolled in MOJAVE, a US randomized controlled Phase 1/2a study of DSR® 2.0 for treatment of congestive heart failure

US study seeking to confirm strong efficacy data reported in RED DESERT and SAHARA Initial data expected in Q4 2023 Ghent, Belgium – 10 July 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that the first patient has […]

Sequana Medical – 1,000th alfapump® implant completed

Extensive real world alfapump experience derisks planned US & Canadian launch Strong clinical alfapump profile demonstrated in North American POSEIDON study All approvals received to commence US MOJAVE study of DSR 2.0 Ghent, Belgium – 06 July 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of fluid overload in liver disease, […]

Sequana Medical announces additional data on safety, quality of life and survival from North American pivotal alfapump® study (POSEIDON)

Data presented at EASL Congress 2023 alfapump was effective in the control of ascites, virtually eliminating needle paracentesis Safety in line with expectations – particularly given disease progression in these patients – six primary safety events and limited number of key secondary safety events Clinically meaningful and statistically significant improvement in patients’ quality of life […]

Sequana Medical wins Best Technology Award for alfapump® at European Mediscience Awards

Ghent, Belgium – 16 June 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that its alfapump has won the ‘Best Technology’ Award at the European Mediscience Awards in London last night. Read more…