Sealant Cleared by FDA for Cranial Surgery

A hemostatic surgical sealant that quickly stops intraoperative bleeding has been cleared for neurosurgical/cranial procedures by the U.S. Food and Drug Administration (FDA). Previously the sealant, called Proceed, had been cleared by the FDA for spinal applications.

Proceed uses a proprietary combination of collagen-derived particles and thrombin that works together with the fibrinogen in a patient's blood to form a natural clot and to seal the bleed. Proceed is sold in the spinal and cranial markets by Sulzer Spine-Tech, Inc., a subsidiary of Sulzer Medica (Winterthur, Switzerland), under a worldwide agreement that that excludes Japan. In multicenter clinical trials, Proceed stopped bleeding within 10 minutes in 96% of cases, compared to 77% of cases using Gelfoam plus Thrombin. Proceed is manufactured by Fusion Medical Technologies Inc, which notes that the sealant has been cleared for all surgical categories except urology and ophthalmology.

"Proceed complements our expanding product line and allows us to offer our surgeons the tools they need during spinal fusion surgery and now for neurocranial surgery,” noted Rich Lunsford, president of Sulzer Spine-Tech.



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