FDA Approves First Cranial Dural Sealant

The FDA has approved Confluent Surgical's DuraSeal Dural Sealant System -- the first and only product indicated as an adjunct to sutured dural repair during cranial surgery to achieve watertight closure -- with a condition to conduct a postapproval study, the company said.

The DuraSeal technology is a patented synthetic, absorbable hydrogel delivered by a dual syringe applicator. The device can be stored at room temperature and prepared in less than two minutes. When sprayed on to the dura, a strong, adherent sealing layer is produced and effectively seals the suture line within seconds. A feature unique to the DuraSeal Sealant is the blue colorant that provides the surgeon excellent visualization of coverage and thickness of the material upon application to the dura.

Postoperatively, the DuraSeal Sealant continues to seal the suture line as healing progresses under the gel. After several weeks, the hydrogel breaks down into water- soluble molecules that are absorbed and cleared through the kidneys.

Clinical results presented to the FDA demonstrated the DuraSeal Sealant was able to achieve watertight closure in 98 percent of cases, immediate sealing was obtained on the first application in 95 percent of cases, and 95 percent of applications were rated as "easy" to "very easy" by neurosurgeons using the product.