Pramand has launched its SpineSeal spine sealant system in the U.S., following recent premarket approval from the U.S. Food and Drug Administration (FDA).

The absorbable polyethylene glycol (PEG) hydrogel is indicated as an adjunct to sutured dural repair during spinal surgery to provide watertight closure. It’s sprayed with an applicator over sutures and forms a watertight seal in a couple of seconds, according to Pramand.

The sealant prevents cerebrospinal (CSF) fluid from leaking out of a spinal durotomy site. Its underlying technology, the company said, has been used for over 20 years in a variety of medical applications.

The rollout of SpineSeal rounds out the company’s sealing portfolio with CraniSeal, giving hospitals cost-effective options for both cranial and spinal dural sealing to avoid post-op CSF leakage.

“We are excited to now offer neuro and orthopedic spine surgeons a choice for spinal dural sealing with the approval and launch of SpineSeal,” said Amar Sawhney, Ph.D., Pramand’s CEO “This, along with our previously approved CraniSeal Dural Sealant System leverage proven, highly effective technology with a long record of safety and efficacy.”

Pramand was founded in 2020 and develops implantable medical devices from novel, proprietary hydrogel materials. Its team has launched over ten medical device companies based on hydrogel technology.