FDAnews Device Daily Bulletin

Covidien Gets Clearance for LigaSure Maryland Sealer Device FDA

Jan. 23, 2014

Covidien says it has received 510(k) clearance for three different lengths of its LigaSure device. The product is used to seal vessels and tissue during minimally invasive and laparoscopic surgeries requiring ligation and division of vessels.

LigaSure combines three surgical tools: a Maryland dissector with a curved jaw for separating, grasping and manipulating tissue; an atraumatic tissue grasper; and cold surgical scissors. The versatile instrument allows surgeons to grasp, seal and cut tissue in fewer steps and with minimal instrument exchanges, the Irish devicemaker says. It also reduces procedure time, minimizes blood loss and shortens hospital stays, compared with traditional sutures, the company adds.

Further, LigaSure contains a sensor that monitors changes in tissue 3,333 times per minute and adjusts the device’s energy output accordingly, Covidien notes.

The company plans to launch the 37 cm LigaSure device in the U.S. shortly and roll out 23 cm and 44 cm versions later this year. Covidien says it has also completed requirements for CE marking and hopes to make the device available in the EU this quarter. — Lena Freund

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