Sequana Medical said it has received investigational device exemption approval from the FDA to conduct a pivotal study of its Alfapump device for patients with recurrent or refractory ascites due to liver cirrhosis.
Alfapump is a fully implantable pump designed to continuously remove excess abdominal fluid in patients with liver disease. Zurich-based Sequana has applied to Health Canada for Investigational Testing Authorisation (ITA) as well. The company won CE Mark approval for the device in 2011.
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