Covidien obtains FDA 510(k) clearance for its LigaSure laparoscopic surgical device

23 January 2014 (Last Updated January 23rd, 2014 01:00)

Covidien has received the US Food and Drug Administration (FDA) 510(k) clearance for the LigaSure Maryland jaw open/laparoscopic sealer/divider, designed to improve efficiency during laparoscopic and open surgical procedures.

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Covidien has received the US Food and Drug Administration (FDA) 510(k) clearance for the LigaSure Maryland jaw open/laparoscopic sealer/divider, designed to improve efficiency during laparoscopic and open surgical procedures.

It combines three surgical tools, a Maryland dissector, or a curved jaw used to manipulate tissue; an atraumatic tissue grasper; and cold surgical scissors. The device allows surgeons to seal and cut tissue with fewer steps and reduced instrument exchanges.

Covidien Advanced Surgical president Chris Barry said: "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 jaw device comes in three lengths, 23cm, 37cm and 44cm. The company plans to launch the 37cm version to select customers in the next couple of months and launch the 23cm and 44cm options later in this year.

"The jaw device comes in three lengths, 23cm, 37cm and 44cm."

The LigaSure Maryland jaw device is designed for use in minimally invasive procedures including urologic, vascular, thoracic and thoracoscopic, and gynaecologic procedures where ligation and division of the vessels is performed.

Covidien also completed all European requirements to CE Mark the product and expects to begin marketing the new device in the EU and the US this quarter.

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. The company's proprietary technology can fuse vessels up to and including 7mm, lymphatics, tissue bundles and pulmonary vasculature.

LigaSure technology has been reportedly used in more than eight million vessel sealing procedures worldwide.


Image: New device provides one-step vessel and tissue sealing. Photo: courtesy of Business Wire/ Covidien plc.