First Biosynthesized Cellulose-Based Dural Substitute Launched

J&J company, DePuy Synthes CMF (craniomaxillofacial) has announced the launch of SYNTHECEL® Dura Repair. This is the first commercially available biosynthesized dural replacement derived from cellulose for use in neurosurgery.

Background

A dural graft, which is either bovine collagen or synthetic, is often required after neurosurgery to close any opening made into the Dura Mater, thereby sealing it in order to protect cerebral tissue and reduce the risk of infection.

SYNTHECEL Dura Repair is composed of naturally formed biosynthesized cellulose and water and is indicated for use as a dura replacement for the repair of dura mater in adults. The implant is non-animal derived and carries no risk of transmissible diseases. With a thickness similar to human dura the product is designed with a unique construction of non-woven, interconnected cellulose fibers that conform to the contours of the brain. DePuy Synthes CMF says SYNTHECEL Dura Repair provides versatility with its excellent onlay or suture performance.

A prospective, randomized multicenter study published in the journal Neurosurgery demonstrated comparable attributes between SYNTHECEL Dura Repair and a control group including all the major dura substitute players, made of bovine collagen and synthetic collagen. Device handling attributes such as strength and seal quality were favored over the control devices for both device strength and seal quality by surgeons during the clinical trial. Indeed, they expressed a statistically significant difference in favor of the new material. In addition, six months after surgery, the cerebrospinal fluid (CSF) leak rate with SYNTHECEL Dura Repair was zero and no adhesions were observed.

SYNTHECEL Dura Repair carries both CE mark and FDA clearance.

Physician comments

“The ideal dural substitute should prevent cerebrospinal fluid leaks, have strength and flexibility similar to human dura mater, present little or no risk of infection and not induce a severe inflammatory response,” said company consultant Frederick F. Marciano, MD, PhD, Barrow Neurosurgical Associates, Scottsdale Healthcare in Arizona, a co-author of the randomized clinical study published in Neurosurgery. “In our study, SYNTHECEL Dura Repair delivered on all these measures, and given its excellent handling characteristics and conformability, provides an excellent choice of implant for a reliable dural repair in standard or complex procedures.”

Company comments

“DePuy Synthes Companies of Johnson & Johnson offers an integrated portfolio of solutions for all types of cranial surgery including dural repair, cranial fixation and cranial reconstruction,” said I.V. Hall, Franchise Unit Leader, DePuy Synthes Trauma, CMF and Vet. “We identified an unmet need for an organic dural replacement and developed SYNTHECEL Dura Repair to provide surgeons and their patients a new option that has the potential to enhance the procedure and improve patient outcomes.”

Source: DePuy Synthes CMF

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