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Product approval

Covidien gains approvals for GIA and Tri-Staple technology

Endo GIA Reinforced Reload with Tri-Staple technology integrates tissue reinforcement buttressing capability with surgical stapling device

Covidien’s Endo GIA Reinforced Reload with Tri-Staple technology has received by US and Japanese regulatory approval. According to the company, American approval extends its ‘industry-leading 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.

The Endo GIA Reinforced Reload, which the company claims is 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 optimise performance during stapling.

“Covidien is committed to developing specialised solutions for our customers that enable better patient outcomes,” said Dr Michael Tarnoff, 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.”

The advanced polymer buttressing material is a version of Neoveil felt, developed by Gunze, which has been in clinical use in the Japanese market for more than 20 years.

“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.”

The American approval followed recent Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its Endo GIA Reinforced Reload with Tri-Staple technology.

“This approval enables Covidien to offer an innovative technology that supports the company’s vision of improving patient outcomes and expanding global access to care,” said Ryo Noda, president, Covidien Japan. “Integrating tissue stapling with buttress provides surgeons with both greater functionality and efficiency.”

Covidien expects to begin offering Endo GIA Reinforced Reload with Tri-Staple Technology in the US and Japanese market in the coming months.

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