Pramand LLC has announced the U.S. commercial launch of the SpineSeal Spine Sealant System following recent premarket approval by the US Food and Drug Administration. SpineSeal is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure.1
SpineSeal is an absorbable polyethylene glycol (PEG) hydrogel that is sprayed with an applicator over sutures and forms a watertight seal within a couple of seconds. This sealant prevents cerebrospinal fluid (CSF) from leaking out of a spinal durotomy site. The underlying technology has been used for over two decades in a variety of medical applications.
Amar Sawhney, Ph.D., Pramand’s CEO, remarked, “We are excited to now offer neuro and orthopedic spine surgeons a choice for spinal dural sealing with the approval and launch of SpineSeal. This, along with our previously approved CraniSeal® Dural Sealant System leverage proven, highly effective technology with a long record of safety and efficacy.” Companies founded by Dr. Sawhney have previously created products like DuraSeal®‡ Dural Sealant and DuraSeal Exact Dural Sealant, which are extensively used for dural sealing globally.
The launch of SpineSeal rounds out Pramand’s dural sealing portfolio with CraniSeal and gives hospitals cost effective solutions for both Cranial and Spinal dural sealing to avoid post-surgical CSF leakage.
For more information about CraniSeal, visit craniseal.com/.
1. PRA-LBL-0031.
‡DuraSeal® is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.
