Covidien gains expanded FDA clearance for small jaw surgical device

Covidien ($COV) scored a victory with the FDA, winning expanded clearance for a small jaw device that aids  surgeons during various procedures.

Covidien, with corporate headquarters in Dublin, Ireland, and Mansfield, MA, gained 510(k) clearance to use its LigaSure curved, small jaw open sealer/divider for ear, nose and throat (ENT) procedures. FDA officials initially granted clearance in February 2011 to use the device just for general surgery.

Companies boost revenue by pursuing expanded indications for devices. Out of $11.6 billion in revenue in 2011, LigaSure sales likely represented a drop in the bucket. But Covidien wants to make those drops bigger. In its approval announcement, Covidien notes that LigaSure can be used for other procedures now, such as thyroidectomies and parotidectomies, according to the company. And gaining even a small portion of that business would help boost LigaSure-generated revenue significantly.

As the company plows ahead with market growth plans for products like LigaSure and its iDrive Ultra power stapler (to seal surgical incisions), it has faced at least one major product setback this summer. Earlier this year, Covidien recalled a number of lots of its Duet TRS device (to reinforce staple lines in tissues after surgery) after it was linked to injuries and three deaths. In the wake of that controversy, Covidien announced it would recall all 540,000 units of the device and end its production.

- read the release

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