Covidien Receives U.S. FDA 510(k) Clearance for Reinforced Stapling Reload Technology

  Covidien Receives U.S. FDA 510(k) Clearance for Reinforced Stapling Reload

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

Business Wire

DUBLIN, Ireland -- February 6, 2014

Covidien plc. (NYSE:COV) announced that the U.S. Food and Drug Administration
has granted 510(k) clearance for the company’s Endo GIA™ Reinforced Reload
with Tri-Staple™ technology. This clearance extends Covidien’s
industry-leading portfolio of advanced surgical staplers and represents a
return by the company to the U.S. market for surgical staplers that integrate
buttress material for additional tissue support.

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.

“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.”

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.

“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.”

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.


Covidien is a leading global healthcare products company that creates
innovative medical solutions for better patient outcomes and delivers value
through clinical leadership and excellence. Covidien develops, manufactures
and sells a diverse range of industry-leading medical device and supply
products. With 2013 revenue of $10.2 billion, Covidien has more than 38,000
employees worldwide in more than 70 countries, and its products are sold in
over 150 countries. Please visit to learn more about our


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