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;
joan.solsman@dowjones.com