UPDATE 2-FDA staff cites benefits of Confluent sealant

Tue May 12, 2009 11:49am EDT

 * 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)


Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.