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Covidien obtains FDA 510(k) approval for Tri-Staple technology

Ireland-based Covidien has obtained the 510(k) approval from the US Food and Drug Administration (FDA) for its Endo GIA reinforced reload with Tri-Staple technology.

The Endo GIA reinforced reload features pre-loaded tissue reinforcement. The new device combines the benefits of Tri-Staple technology with a pre-attached synthetic, porous buttress material that is a version of Neoveil felt developed by Gunze.

The porous buttress material provides additional support to fragile tissue that is being stapled and resected. It has been in clinical use in the Japanese market for more than 20 years.

All Endo GIA reloads with Tri-Staple technology have been developed to work in harmony with the natural properties of tissue to optimize performance during stapling.

Covidien claims that the FDA 510(k) clearance extends the company’s portfolio of advanced surgical staplers and represents a return by the company to the US market for surgical staplers that integrate buttress material for additional tissue support.

Covidien chief medical officer Dr Michael Tarnoff noted the company is committed to developing specialized solutions for its customers that enable better patient outcomes.

"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," Dr Tarnoff added.

Covidien obtained Shonin approval in January 2014 from the Japanese Ministry of Health, Labor and Welfare for the Endo GIA reinforced reload with Tri-Staple technology.

The company anticipates launching the new device in the US and Japanese markets in the coming months.