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FDA clears Contego Medical’s Paladin carotid balloon

September 18, 2018

Contego Medical said today that it won 510(k) clearance from the FDA for its Paladin carotid balloon with embolic protection.

Raleigh, N.C.-based Contego said the Paladin device consists of an angioplasty balloon and a 40-micron filter for carotid stenting procedures. It won CE Mark approval in 2015 in the European Union, where it launched the following January.

A post-market surveillance study of 106 patients showed a 0.9% risk of death, stroke and myocardial infarction at 30 days and zero procedural strokes, the company said.

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