UPDATE 2-FDA staff cites benefits of Confluent sealant
* Duraseal offers clinical benefits-FDA
* FDA staff sees no significant safety problems
* Product easier to use than alternatives, staff says
* Covidien shares up 2 pct (Adds company comment, background on product)
By Susan Heavey
WASHINGTON, May 12 (Reuters) - Confluent Surgical Inc's Duraseal Xact Sealant System offers benefits over current options in preventing leaks after spine surgeries, U.S. health regulatory staff said in documents released on Tuesday.
The company, now part of Covidien Ltd (COV.N), is seeking U.S. Food and Drug Administration approval to market the new spinal use for Duraseal, a type of polymer that is sprayed onto the surgical site to provide a watertight seal. It is already FDA-approved for cranial surgeries.
Shares of Covidien rose as much as 2.6 percent on Tuesday morning.
On Thursday, the FDA will ask a panel of outside experts whether it should approve the new use. It usually, but not always, follows their advice.
While both Duraseal and current sealing options showed the same rate of leaks 90 days after a surgical procedure, Confluent's product offered numerous clinical benefits without significant safety concerns, FDA staff said in documents released ahead of Thursday's meeting.
"Duraseal is easier to use and takes less time than applying additional sutures, harvesting and sewing in muscle or fascial patches, or using fibrin glue which takes significant time to mix and heat," the staff wrote in a summary.
Agency reviewers also noted that Duraseal was superior to current options in preventing leaks during surgery.
Water-tight seals are critical for brain and spinal surgeries to prevent cerebral spinal fluid from leaking after the surgical opening is sewn shut, Confluent said in a separate document also released on Tuesday.
Advances in surgical techniques have allowed doctors to treat a growing number of neurological conditions, but "surgeons do not have a safe and effective, FDA approved, adjunct to suturing," the company wrote.
Sutures can leave small gaps that can allow leaks, which may delay healing as well as trigger headaches or other complications, such as bacterial meningitis, Confluent has said.
Covidien spokeswoman Diana Sousa declined to say how much revenue Duraseal already brings in for its cranial use. But she said the overall market for surgical sealants in 2009 worldwide is estimated at more than $2 billion, citing data from MedMarket Diligence.
Shares of Covidien were up 65 cents or 1.9 percent at $34.36 on the New York Stock Exchange around midday, off an earlier high at $34.58. (Reporting by Susan Heavey, editing by Maureen Bavdek and Matthew Lewis)
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