Sequana Grabs FDA’s Investigational Device Exemption for Abdominal Pump Trial

Sequana Medical’s Alfapump device has received investigational device exemption (IDE) approval from the FDA to begin a pivotal study for patients with abdominal swelling caused by liver cirrhosis.

The Swiss devicemaker’s Alfapump is used to regularly remove excess abdominal fluid. The company plans to enroll 60 patients in the trial that will be implanted with the device for primary endpoint analysis.

Sequana company received the CE Mark for the device in 2011 and has petitioned Health Canada for investigational testing authorization as well.