Devices Surgery FDA

 News Release - January 8, 2009

Covidien Receives FDA Clearance to Market SILS(TM) Port Multiple Instrument Access Port

New Device Will Enable SILS(TM) Procedures

NORTH HAVEN, Conn., Jan. 8, 2009--(HSMN NewsFeed)--Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, today announced that its Surgical Devices business unit has received 510(k) clearance from the U.S. Food and Drug Administration to market the Covidien SILS(TM) Port Multiple Instrument Access Port for laparoscopic surgeries through a single incision.

The SILS(TM) Port is a single, flexible port that can be fitted through a small incision in the umbilicus which results in a single "hidden scar," a cosmetic advance over the multiple visible scars associated with standard multi-port laparoscopy. The port has the capacity for up to three laparoscopic instruments.

"SILS(TM) Port is the first device specifically indicated for multiple instrument access to the abdomen through a single incision," said Scott Flora, President, Surgical Devices, Covidien. "We led the first surgical revolution with multi-port laparoscopic surgery and Covidien is now leading the way again with SILS(TM) procedures and the new SILS(TM) Port, innovations that offer surgeons an immediate advancement in patient care," he added.

Laparoscopic procedures performed through a single incision are a significant evolution in the world of surgery. While laparoscopy traditionally offers better patient outcomes including less pain and improved cosmesis than the open approach, SILS(TM) procedures have the potential to dramatically extend these benefits. The SILS(TM) Port is scheduled for commercialization in the United States and Europe later this year.

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 manufactures, distributes and services a diverse range of industry-leading product lines in four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2008 revenue of nearly $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

Source: Covidien

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