Biosynthesized Dural Replacement from DePuy Synthes Covers and Protects Brain and Spinal Cord Tissue

West Chester, Pa.-based DePuy Synthes CMF, a division of DePuy Orthopaedics Inc., has released its Synthecel dura repair, a 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, often is 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. In addition, six months after surgery, the cerebrospinal fluid 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 matter, present little or no risk of infection and not induce a severe inflammatory response,” said Frederick F. Marciano, M.D., Ph.D., of 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, the company claims. With a thickness similar to human dura, Synthecel dura repair is designed with a 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 Veterinary. “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.”

DePuy Synthes CMF makes 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.