Sequana Medical Reports the Submission of Premarket Approval Application to the US FDA for alfapump to Treat Ascites due to Liver Cirrhosis
Shots:
- The PMA filing was made based on the (POSEIDON) clinical trial evaluating the safety & efficacy of alfapump in liver ascites patients (n=69) across 18 centers in the US & Canada
- The effectiveness of alfapump exceeded the predefined thresholds with statistical significance at 6mos. post-implantation whereas the safety results were in line with the expectations. Moreover, the 12mos. data depicted a strong & durable clinical profile, eliminated the need for therapeutic paracentesis & improved QoL in patients
- alfapump is an implantable wirelessly charged device designed for patients with r/r ascites due to liver cirrhosis. Earlier in 2019, alfapump received the US FDA’s BTD
Ref: Sequana Medical | Image: Sequana Medical
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
