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Covidien Receives Japanese Regulatory Approval For Reinforced Stapling Reload Technology

Covidien plc (NYSE: COV) today announced that its Japanese subsidiary, Covidien Japan Inc., has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its Endo GIA™ Reinforced Reload with Tri-Staple™ technology. This approval extends Covidien’s industry-leading portfolio of advanced surgical staplers and represents a return by the company to the Japanese stapling buttress market.

The newly approved Endo GIA Reinforced Reload will enable surgeons to deliver an advanced polymer felt material to provide additional support to fragile tissues when deploying Covidien’s Tri-Staple™ surgical stapling technology. The buttressing material itself is a version of NEOVEIL® felt, developed by GUNZE Ltd., which has been validated clinically in the Japanese market for more than 20 years.

“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 Japanese market in the coming months.

About Covidien

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 business.


Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or Company actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, our ability to effectively introduce and market new products, keep pace with advances in technology and compete effectively, implementation of healthcare reform in the United States and globally, cost-containment efforts of customers, purchasing groups, third-party payors and governmental organizations, rising commodity costs, risk of cyber-attacks, intellectual property rights disputes, complex and costly regulation, including healthcare fraud and abuse regulations and the Foreign Corrupt Practices Act, recalls or safety alerts and negative publicity relating to Covidien or its products, product liability losses and other litigation liability, manufacturing or supply chain problems or disruptions, divestitures of some of our businesses or product lines, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, risks associated with doing business outside of the United States, foreign currency exchange rates, environmental liabilities and tax legislation and potential tax liabilities. These and other factors are identified and described in more detail in our Annual Report on Form 10-K for the fiscal year ended September 27, 2013, and in subsequent filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.

Copyright Business Wire 2010

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