DePuy Synthes CMF Launches First Biosynthesized Cellulose-Based Dural Replacement For Neurosurgery

WEST CHESTER, Pa., May 4, 2015 /PRNewswire/ -- DePuy Synthes CMF* today announced the launch of SYNTHECEL^® Dura Repair, the first commercially available biosynthesized dural replacement derived from cellulose for use in neurosurgery. DePuy Synthes CMF is a part of the DePuy Synthes Companies of Johnson & Johnson.

The dura is a tissue membrane that covers and protects the brain and spinal cord. During neurosurgery, the dura may be cut to allow surgeons to access the brain. A dural graft, which is either bovine collagen or synthetic, is often required after interdural surgery to provide a watertight seal, protect cerebral tissue and reduce the risk of infection.

A prospective, randomized multicenter study published in the journal Neurosurgery demonstrated comparable attributes between SYNTHECEL Dura Repair and a control group of commonly used dura substitutes made of  bovine collagen and synthetic collagen. Device handling attributes such as strength and seal quality were evaluated by surgeons during the clinical trial.  Surgeons expressed a statistically significant difference in favor of SYNTHECEL Dura Repair over the control devices for both device strength and seal quality.¹ In addition, six months after surgery, the cerebrospinal fluid (CSF) leak rate with SYNTHECEL Dura Repair was zero and no adhesions were observed.

"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 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."

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,^2,3 SYNTHECEL Dura Repair is designed with a unique construction of non-woven, interconnected cellulose fibers that conform to the contours of the brain. SYNTHECEL Dura Repair provides versatility with its excellent onlay or suture performance.

"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."

About DePuy Synthes CMF
DePuy Synthes CMF offers a comprehensive portfolio of implant systems for surgeons to treat patients who have sustained conditions affecting the face, head, neck and thorax, including solutions for craniomaxillofacial, sternum and rib fixation. DePuy Synthes CMF is part of the DePuy Synthes Companies of Johnson & Johnson, the largest provider of orthopaedic and neurological solutions in the world. For more information visit, www.depuysynthes.com.

*DePuy Synthes CMF is a division of DePuy Orthopaedics, Inc.

**Consultant to DePuy Synthes CMF

©DePuy Synthes 2015.  All rights reserved.

¹ Rosen, Charles L., et al. Results of Prospective, Randomized, Multicenter Clinical Trial Evaluating a Biosynthesized Cellulose Graft for Repair of Dural Defects. Neurosurgery. 2011 Nov; 69(5):1093-103;discussion 1103-4. Control group: Duraform Dural Graft implant (15 units), Duragen II Dural Regeneration Matrix (8 units), Duragen Dural Graft Matrix (10 units), Durepair Regeneration Matrix (2 units), Duragen Plus (1 unit), and Preclude Dura Substitute (1 unit).
² Ontano SE, et al. Mechanical behavior of human dura mater. Transcripts from BED Bioeng Con- ASME 29:329-300, 1995.
³ Sacks MS, et al. Local mechanical anisotropy in human cranial dura mater allografts. J Biomech Eng 120:541-544, 1998.

SOURCE DePuy Synthes CMF