Covidien Receives U.S. Food and Drug Administration Clearance for LigaSure™ Maryland Jaw

New device provides one-step vessel and tissue sealing

Improves efficiency during laparoscopic and open procedures

BOULDER, Colo.--()--Expanding its industry-leading vessel and tissue sealing portfolio, Covidien (NYSE:COV) received U.S. Food and Drug Administration (FDA) 510(k) clearance for the LigaSure™ Maryland jaw open/laparoscopic sealer/divider. In addition, Covidien completed all European requirements to CE Mark the product. The company expects to launch the new vessel sealer and divider in the United States and the European Union during the current quarter.

Designed to improve efficiency during laparoscopic and open surgery, the LigaSure Maryland jaw device combines LigaSure’s energy-based vessel sealing technology with the functionality of three common surgical tools: a Maryland dissector, which is a blunt surgical tool with a curved jaw used to separate, grasp and manipulate tissue; an atraumatic tissue grasper and cold surgical scissors. The design of the new LigaSure Maryland jaw device allows surgeons to grasp, seal and cut tissue with minimal steps and reduced instrument exchanges.

“For more than 15 years, surgeons have trusted LigaSure technology for its ability to reduce blood loss,1,2 shorten procedure time1,2 and shorten the length of hospital stay1 compared to sutures,” said Chris Barry, President, Advanced Surgical, Covidien. “The LigaSure Maryland jaw offers surgeons an efficient, versatile and multifunctional option for one-step sealing and further demonstrates Covidien’s commitment to expand energy device options with solutions targeted at specific procedures and surgeon use needs.”

Setting the industry standard, LigaSure technology has been used in more than 8 million vessel sealing procedures worldwide.

LigaSure vessel sealing technology is powered by the ForceTriad™ energy platform, controlled by TissueFectTM sensing technology, which monitors changes in tissue 3,333 times per second and adjusts energy output accordingly to deliver the appropriate amount of energy for the desired tissue effect. LigaSure vessel sealing uses the body’s own collagen and elastin to create a permanent fusion zone. Covidien’s proprietary technology can fuse vessels up to and including 7 mm, lymphatics, tissue bundles and pulmonary vasculature.

The LigaSure Maryland jaw device comes in three lengths. Covidien plans to roll out the 37 cm version to select customers early in 2014 and launch the shorter 23 cm and longer 44 cm options later this year. Covidien designed the LigaSure Maryland jaw device for use in minimally invasive procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed.

For more information on LigaSure products, visit: http://surgical.covidien.com/products/vessel-sealing#technology

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 www.covidien.com to learn more about our business.

1 Ding Z, Wable G, Rane A. Use of Ligasure bipolar diathermy system in vaginal hysterectomy. J Obstet Gynaecol. 2005;25(1): 49-51.

2 Levy B, Emery L. Randomized trial of suture versus electrosurgical bipolar vessel sealing in vaginal hysterectomy. Obstet Gynecol. 2003;102(1):147-151.

Contacts

Covidien plc
John Jordan, 508-452-4891
Manager, Communications
john.jordan@covidien.com
or
Coleman Lannum, CFA, 508-452-4343
Vice President, Investor Relations
cole.lannum@covidien.com
or
Marguerite Copel, 203-821-4720
Vice President, Communications
marguerite.copel@covidien.com
or
Todd Carpenter, 508-452-4363
Senior Director, Investor Relations
todd.carpenter@covidien.com

The U.S. Food and Drug Administration cleared Covidien's LigaSure Maryland jaw vessel sealer and divider in three lengths for use in open and laparoscopic surgery. (Photo: Business Wire)

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Release Summary

Expanding its industry-leading vessel and tissue sealing portfolio, Covidien received U.S. FDA 510(k) clearance for the LigaSure™ Maryland jaw open/laparoscopic sealer/divider.

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Contacts

Covidien plc
John Jordan, 508-452-4891
Manager, Communications
john.jordan@covidien.com
or
Coleman Lannum, CFA, 508-452-4343
Vice President, Investor Relations
cole.lannum@covidien.com
or
Marguerite Copel, 203-821-4720
Vice President, Communications
marguerite.copel@covidien.com
or
Todd Carpenter, 508-452-4363
Senior Director, Investor Relations
todd.carpenter@covidien.com