* Advisers recommend Duraseal for spinal surgery 4-0
* Panelists call for further study after approval (Adds comments, reaction, background on product)
GAITHERSBURG, Md., May 14 (Reuters) - A U.S. Food and Drug Administration advisory panel recommended expanding approval of Covidien Ltd’s COV.N Duraseal sealant for use in spinal surgeries as long as the company gathers more data.
The panel of outside experts voted 4-0 in favor of the product, which is already FDA-approved for use in cranial surgeries. The agency will weigh the panel’s recommendation in making its final decision.
Covidien is seeking FDA approval to more widely market Duraseal, a synthetic polymer that is sprayed onto the surgical site to provide a watertight seal, for use in addition to traditional sutures.
Properly closing incisions in brain and spinal surgeries prevents cerebral spinal fluid from leaking, which can cause complications such as infection.
But surgical sutures alone can leave small gaps. Currently, surgeons use additional stitches, soft tissue patches or unapproved glues to try to further prevent leaks.
“There are currently no approved products for this indication,” said Xavier Lefebvre, clinical vice president for Covidien’s device unit, formerly Confluent Surgical Inc.
Panelists expressed some concern about the product, saying there was no clear difference in fluid leakage 90 days after surgery, even though the data showed Duraseal worked better than alternative methods during surgery itself.
If the FDA approves Duraseal, it should require Covidien to collect more data for at least three months, the panel said.
“I do think we have inadequate data... particularly the long-term leakage rates, possibly infection,” said panelist Dr. Edward Hanley, a North Carolina orthopedic surgeon.
Overall, though, panelists said the data was acceptable.
“The key point here is (this is) an aid for the surgeon at the point when he or she is having trouble closing” a surgical opening, said Dr. Michael Yaszemski, a panel member and Minnesota spinal surgeon.
But Dr. Peter Lurie, deputy director of consumer advocacy group Public Citizen’s Health Research Group, told the panel that not enough patients were studied to show meaningful benefits.
Results also showed Duraseal reduced surgical times by just about 3 minutes for procedures that generally last more than 3 hours, Lurie said.
The company looked at 158 patients, with 102 given Duraseal and 56 treated with other methods, according to the FDA.
“We’re approving this for patients not for doctors,” Lurie told the panel. “We need to see rigorously controlled data, and these data are not it.”
Covidien spokeswoman Diana Sousa could not say when the company expected the FDA to make a decision.
The company declined to give Duraseal’s current revenues for cranial use but said more than 1.6 million U.S. spine surgeries are likely in 2009, citing MedTech Insight data. (Reporting by Susan Heavey; Editing by Phil Berlowitz and Tim Dobbyn)