Cook Medical has introduced Biodesign duraplasty graft, a new treatment option designed for otolaryngologists (ear, nose and throat specialists) who repair the dura mater following cerebrospinal fluid (CSF) leaks at the base of the skull.
The graft is a nonporous, absorbable multi-layer sheet of extracellular collagen matrix derived from porcine small intestinal submucosa, is easy to manipulate, and does not swell with hydration or fold onto itself.
The graft is non-pyrogenic and has sufficiently low endotoxin levels to make it suitable for applications, where it will contact cerebrospinal fluid during repair of dura mater.
It serves as a scaffold that allows the body to restore itself. Once the graft is in place, the body begins remodelling the graft and leaves behind patient tissue that maintains long-term strength and helps prevent CSF leaks.
As Biodesign is non-dermis based and non-cross-linked, the body can remodel it into strong, well-vascularised tissue.
The graft can be placed with or without sutures and achieve a strong seal, so it provides a well-balanced treatment option for dura mater repair at the skull base.
In a letter to the US Food and Drug Administration (FDA), University of Alabama at Birmingham director of otolaryngology research Dr Bradford A Woodworth said: “Although not directly measured, I feel it contributes to faster graft placement and increased operative speed.”
It is the latest Biodesign product from Cook Medical’s Otolaryngology – Head and Neck Surgery (OHNS) clinical division.
In January, the Biodesign duraplasty graft has been cleared by the FDA for use as a dura substitute for the repair of dura mater.
Cook’s proprietary Biodesign graft technology has been used since 1998 to treat more than 750,000 patients worldwide.
Cook Medical global clinical division leader Thomas Cherry said Biodesign’s proven tissue repair technology works in different grafting procedures.
“We’re excited to introduce the device to otolaryngologists and expand OHNS’s Biodesign line,” Cherry said.
“Because of Biodesign’s excellent handling characteristics, physicians can secure the Biodesign graft during skull-base dura mater reconstruction with or without suturing.”
Image: Biodesign Duraplasty Graft. Photo: courtesy of Cook Medical / Business Wire.