Sealant System for Cranial Surgery

A new system is designed as an adjunct to sutured dural repair during cranial surgery to achieve watertight closure. The system has been cleared by the U.S. Food and Drug Administration (FDA) with a condition to conduct a post-approval study.

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

Postoperatively, the 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 studies show that the sealant can achieve watertight closure in 98% of cases, with immediate sealing obtained on the first application in 95% of cases. Neurosurgeons using the product rated 95% of applications as "easy” to "very easy.”

"Watertight closure of the dura has to date been an elusive goal,” noted Harry van Loveren, M.D., chairman of the department of neurosurgery, University of South Florida (St. Petersburg, USA) and principal investigator in a multi-center study. "I'm confident it will have a profound effect on my cranial procedures.”

DuraSeal is the product of Confluent Surgical (Waltham, MA, USA), a private medical device company pioneering the development of in-situ polymerized biomaterials that are safe, simple to use, and allow the formation of customized implants at the disease site.




Related Links:
Confluent Surgical