FDA 510(k) Clearance for Covidien’s Endo GIA™ Reinforced Stapling Reload Technology

Covidien plc. has seen the U.S. FDA grant it 510(k) clearance for the Endo GIA™ Reinforced Reload with Tri-Staple™ technology. This clearance represents a return by the company to the U.S. market for surgical staplers that integrate buttress material for additional tissue support.

Background

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. All Covidien Endo GIA reloads with Tri-Staple technology are designed to work in harmony with the natural properties of tissue to optimize performance during stapling.

The advanced polymer buttressing material is a version of NEOVEIL® felt, developed by GUNZE Ltd., which has been in clinical use in the Japanese market for more than 20 years. 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 expects to offer the new product in the U.S. and Japanese markets in the coming months.

Company comments

“Covidien is committed to developing specialized solutions for our customers that enable better patient outcomes,” said Michael Tarnoff, M.D., chief medical officer, Covidien. “This unique technology provides improved ease of use and reduced time in the operating room by eliminating extra steps, reducing procedure time and providing surgeons with an integrated, clinically validated buttress material for added security at the staple line.”

“Our Tri-Staple platform of stapling products represents the most successful product line in Covidien’s history,” said Chris Barry, president, Advanced Surgical, Covidien. “This all-in-one solution advances our leadership in surgical stapling and meets an important customer need.”

Source: Covidien, Business Wire

 

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