FDA Clearance for Covidien LigaSure™ Maryland Jaw

Covidien has received U.S. FDA 510(k) clearance for the LigaSure™ Maryland jaw open/laparoscopic sealer/divider. In addition, the company has completed all European requirements to CE Mark the product. It is expected to launch the new vessel sealer and divider in the United States and the European Union during the current quarter.


The LigaSure Maryland Jaw device will complement Covidien’s vessel and tissue sealing portfolio. The company says its device is designed to improve efficiency during laparoscopic and open surgery, combining 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.

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.

Company comments

“For more than 15 years, surgeons have trusted LigaSure technology for its ability to reduce blood loss, shorten procedure time and shorten the length of hospital stay 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.”

Source: Covidien, PLC., Business Wire

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