BioGlue and spine surgery

Abstract

I read with great interest the article by Epstein [ [1] Epstein N.E. Dural repair with four spinal sealants: focused review of the manufacturers’ inserts and the current literature. Spine J. 2010; 10: 1065-1068 Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar ]. The author presents a focused review of the US manufacturers’ inserts and literature concerning two “sealants,” DuraSeal (Confluent Surgical, Inc., Waltham, MA, USA) and BioGlue (CryoLife, Inc., Kennesaw, GA, USA) and two “fibrin glues,” EVICEL (Johnson and Johnson Wound Management, Ethicon, Inc., Somerville, NJ, USA) and Tisseel (Baxter International, Inc., Westlake Village, CA, USA), with the aim to discuss the possible risks and complications of their use in spine surgery. Dural repair with four spinal sealants: focused review of the manufacturers’ inserts and the current literatureThe Spine JournalVol. 10Issue 12PreviewDeliberate or traumatic dural fistulas are typically augmented by a “sealant” or “fibrin glue” to enhance the strength of dural closure. Full-Text PDF Epstein respondsThe Spine JournalVol. 11Issue 10PreviewI thank the reviewer for taking the time and effort to comment on the article “Dural repair with four spinal sealants: focused review of the manufacturers’ inserts” [1]. The reviewer raised several valid and interesting points that I will sequentially address. Full-Text PDF Dural repairs with spinal sealantsThe Spine JournalVol. 12Issue 3PreviewDr Epstein [1,2] and Dr Miscusi [3] have discussed the use of sealants to augment dural closure. The US Food and Drug Administration has not evaluated the safety and effectiveness of Evicel, Tisseel, or BioGlue for duraplasty. As Dr Epstein [1] notes, the Contraindications section of the package insert for BioGlue states that “BioGlue for use in neurosurgery, including use as a dural sealant, is not an approved indication.” Prelicensure clinical trials for drug approval are designed to evaluate a medication’s safety and effectiveness for a specific indication. Full-Text PDF