FDA Panel Recommends Approval for Duraseal in Spinal Surgery
BY LAUREN UZDIENSKI, MAY 22, 2009
Last week an FDA panel voted 4-0 in favor of broadening the approved applications for Covidien's Duraseal sealant to include spinal surgery. Duraseal is a resorbable polymer gel designed, along with sutures, to close small gaps in the dura mater after an incision and prevent spinal fluid from leaking. Duraseal, which came on the market for cranial applications in 2005, would be the first product approved for this indication in spine.
To support their application, Covidien submitted data on 158 patients, with 102 given Duraseal and 56 treated with other methods, which may have included additional sutures, tissue patches or glues. Some panelists raised concerns about outcomes, noting that fluid leakage rates 90 days after surgery may have been on par with the control groups. Still, surgeons had better results with Duraseal during the surgery itself, likely on account of ease of use (the product requires about two minutes of prep, sprays on and is blue, so it's visible on the site). These benefits included a small reduction in OR time.
To address the long-term leakage rates, the panel included a post-market study among their recommended conditions for approval. The panel determined that study should include follow-up of at least three months to gauge post-op leakage and infection rates.
While they declined to give revenues for Duraseal, Covidien says there will be about 1.6 million spine surgeries in 2009, representing a substantial opportunity for growth in the sealant market. Currently, competitor products are still pre-market, though Baxter is currently enrolling a craniotomy study to evaluate a fibrin sealant the company is developing.
