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| Synthecel dural replacement--Courtesy of DePuy |
Johnson & Johnson's ($JNJ) DePuy Synthes CMF, a unit of the business focused on surgical products for the head, neck and thorax, has launched Synthecel, the first marketed dural replacement made of cellulose for use in brain surgery.
The launch has been a long time coming. Synthecel was cleared by the FDA in January 2012. This was a Synthes product and may have fallen by the wayside in the process of the June 2012 acquisition of Synthes by Johnson & Johnson for $19.7 billion in cash and stock
Dural replacements are commonly used but are typically made of bovine or synthetic collagen. So, this gives surgeons a product option that's comprised of organic material, but one that is not animal-derived--thereby eliminating that potential route for disease transmission.
DePuy Synthes "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 of DePuy Synthes Trauma, CMF and Vet, in a statement.
"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," he added. The dura is the outermost membrane that covers the brain and the spinal cord.
The study results that supported the approval were published in the journal Neurosurgery in 2011. In that randomized, controlled trial, 99 patients having intradural cranial surgery received either Synthecel or another dural substitute made of bovine collagen and synthetic collagen.
The study found Synthecel to be noninferior to the control group, with overall success achieved in a similar rate of about 97% patients in both groups. No significant differences were found in infection, wound healing or radiological assessment of fluid collection and absence of cerebrospinal fluid fistula at 6 months.
The researchers also said Synthecel provided better strength and seal quality than the other dural substitutes, giving it another potential advantage in addition to the hypothetical advantage of reduced disease risk from prions or other infectious agents.
"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 Dr. Frederick Marciano of Barrow Neurosurgical Associates in Scottsdale, AZ, a co-author of this trial, in the statement.
"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," he concluded.
- here is the release
- here is the trial info from clinicaltrials.gov