06.02.2014 14:45:38
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Covidien Says FDA OKs Endo GIA Reinforced Reload With Tri-Staple Technology
(RTTNews) - Covidien plc. (COV) said Thursday it received U.S. FDA's 510(k) clearance for its Endo GIA Reinforced Reload with Tri-Staple technology. The Endo GIA Reinforced Reload -- the only endoscopic stapler featuring pre-loaded tissue reinforcement -- combines the benefits of Tri-Staple technology with a pre-attached synthetic, porous buttress material that provides additional support to fragile tissue that is being stapled and resected.
In January, Covidien received Shonin approval from the Japanese Ministry of Health, Labor and Welfare for the Endo GIA Reinforced Reload with Tri-Staple technology.
Covidien added it expects to offer the new product in the U.S. and Japanese markets in the coming months.
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