Covidien has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its LigaSure Maryland jaw open/laparoscopic sealer/divider, designed to improve efficiency during laparoscopic and open surgery.
Its design allows surgeons to grasp, seal and cut tissue with minimal steps and reduced instrument exchanges.
The new 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.
LigaSure vessel sealing technology is powered by the ForceTriad energy platform, which features TissueFect sensing technology and enhanced LigaSure tissue fusion technology.
TissueFect sensing technology 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.
The enhanced LigaSure tissue fusion technology permanently fuses vessels up to and including 7mm, lymphatics, pulmonary vasculature and tissue bundles
Covidien’s LigaSure Maryland jaw device is available in three lengths. The company plans to launch the 37cm version to select customers early in 2014 and launch the shorter 23cm and longer 44cm options later 2014.
Covidien Advanced Surgical president Chris Barry noted 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.
"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," Barry added.
Covidien has also completed all European requirements that are required for CE Mark approval of the new vessel sealer and divider. The company anticipates launching the device in the US and EU in the first quarter of 2014.
The LigaSure technology has been used in more than eight million vessel sealing procedures across the globe.
Image: Covidien receives FDA 510(k) approval for LigaSure Maryland jaw. Photo: Courtesy of Businesswire/Covidien.