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. 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. Results also showed Duraseal reduced surgical times by just about 3 minutes for procedures that generally last more than 3 hours.
The company looked at 158 patients, with 102 given Duraseal and 56 treated with other methods, according to the FDA. 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)
NORTH HAVEN, Conn.–(BUSINESS WIRE)–Nov. 11, 2009– Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the launch of DuraSeal™ spine sealant, the first product approved by the U.S. Food and Drug Administration (FDA) for intra-operative sealing of the dural membrane during spine procedures. Nearly 1.5 million spine surgeries are performed in the U.S. every year, with an estimated 10% of these surgeries requiring dural repair and sealing. (more…)