Covidien: FDA OKs Spine Sealant, To Launch In Next Few Weeks

Covidien PLC (COV) said the Food and Drug Administration has approved its product to seal tissue tears that occur during spine surgery.

Sales for spinal use of Duraseal, which is already approved for use during brain surgery, should begin in the coming weeks. The product closes and seals tears in the dura membrane, a watertight tissue that holds in spinal fluid. Covidien said dural tears occur in 10% of spinal surgeries.

In a study, DuraSeal delivered a watertight seal made during surgery whenever it was used, according to the medical-device maker. The product needs two minutes to prepare and three seconds to set, letting surgeons continue with their procedures quickly.

A similar product for cranial surgery was approved in 2005.

Last week, Covidien said it was selling its sleep-diagnostics and oxygen therapy product lines, while it proposed to sell its sleep-therapy business as it stopped shopping the sale of its specialty chemicals unit.

The company has been relatively shielded from cutbacks in hospital spending because it sells mostly less-expensive commodity-type medical products and equipment that won't pressure budgets. But it is more vulnerable than most to currency fluctuations, as more than half of its operating income comes from international markets.

Covidien shares closed Friday at $39.60 and weren't active premarket.

-By Joan E. Solsman, Dow Jones Newswires; 212-416-2291; [e-mail]