FDA clearance for LigaSure Maryland jaw

Expanding its industry-leading 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. 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 time^1,2 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 7mm, lymphatics, tissue bundles and pulmonary vasculature.

The LigaSure Maryland jaw device comes in three lengths. Covidien plans to roll out the 37cm version to select customers early in 2014 and launch the shorter 23cm and longer 44cm 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.

Source: Covidien

^{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}