New Laparascopic Device from Covidien Gets U.S. and European OK

Expanding vessel and tissue sealing portfolio, Covidien received U.S. Food and Drug Administration (FDA) 510(k) clearance for the LigaSure Maryland jaw open/laparoscopic sealer/divider. The company also received CE Mark for the product. Covidien will launch the device in the United States and European Union during the current quarter.

The device is designed for minimally invasive procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed.

Designed to improve efficiency during , the LigaSure Maryland jaw device combines LigaSure’s energy-based vessel sealing technology with 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 device allows surgeons to grasp, seal and cut tissue with minimal steps and reduced instrument exchanges, according to the company.

“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 of Covidien’s Advanced Surgical division. “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.”

The company reports that LigaSure technology has been used in more than 8 million vessel sealing procedures worldwide.

LigaSure is powered by the ForceTriad energy platform, controlled by TissueFect 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 shortly and launch the shorter 23 cm and longer 44 cm options later this year.