Covidien Gets FDA Clearance For LigaSure Maryland Jaw

(RTTNews) - Covidien (COV) said that it received U.S. Food and Drug Administration or FDA 510(k) clearance for the LigaSure Maryland jaw open/laparoscopic sealer/divider. The company expects to launch the new vessel sealer and divider in the United States and the European Union during the current quarter.

In addition, Covidien said it completed all European requirements to CE Mark the product. 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 company said.

The company noted that the design of the new LigaSure Maryland jaw device allows surgeons to grasp, seal and cut tissue with minimal steps and reduced instrument exchanges.

According to the company, LigaSure vessel sealing technology 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.

The company noted that it 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. The firm 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.