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Medical Devices / Submissions and Approvals

Merit Medical Gets Trifecta of FDA Clearances

Dec. 17, 2014

Disposables devicemaker Merit Medical Systems received a trifecta of 510(k) clearances from the FDA for its ReSolve biliary locking drainage catheter, ONE Snare endovascular microsnare system and AEROmini tracheobronchial stent system. The products will launch early in the coming year, Chairman and CEO Fred Lampropoulos tells Device Daily Bulletin.

The ReSolve catheter combines with Merit’s Revolution catheter securement device or the StayFIX fixation device and is magnetic resonance-conditional, allowing for it be safely scanned immediately after placement, according to the South Jordan, Utah, company.

The ONE Snare suite of endovascular snares are available in 15 kit configurations with 10 loop diameters ranging from 2 mm to 35 mm, the company says. These give physicians additional options when foreign body manipulation or retrieval procedures arise, Merit notes.

The AEROmini — a smaller version of the company’s AERO fully covered tracheobronchial stent — is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. — Kellen Owings

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