Covidien received FDA 510(k) clearance for the Endo GIA Reinforced Reload with Tri-Staple technology. The new stapler features a layer of NEOVEIL, a polymer porous felt developed by GUNZE (Osaka, Japan), as a buttressing material.
The layer of NEOVEIL provides support to the tissue that’s being stapled or resected, particularly benefiting fragile tissue such as in the lungs that may otherwise sustain damage during the procedure.
From the announcement:
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 byGUNZE 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. Covidienexpects to offer the new product in the U.S. and Japanese markets in the coming months.
Press release: Covidien Receives U.S. FDA 510(k) Clearance for Reinforced Stapling Reload Technology…