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Medical Devices / Submissions and Approvals

Entellus Medical Gains FDA Clearance for Eustachian Tube Indication

April 14, 2017
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Minnesota–based Entellus Medical has received FDA marketing clearance for its XprESS ENT dilation system in patients with persistent eustachian tube dysfunction (ETD).

The 510(k) clearance was based on clinical trial results that showed no complications or side effects.  A total of 60 patients were randomized to either Eustachian tube dilation using XprESS or control using continued medical therapy. 

The total data for the clinical trial will be submitted by September 2017. — Cynthia Jessup

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