New ViviGen Formable™ Cellular Bone Matrix Launched by DePuy Synthes February 13, 2017

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J&J company DePuy Synthes, in collaboration with LifeNet Health®, has launched ViviGen® Formable™ Cellular Bone Matrix**, a second generation cellular allograft used to assist in the formation of bone during spinal fusion surgery.

Background

DePuy Synthes has an exclusive worldwide agreement to market and promote ViviGen and now ViviGen Formable, which augments the DePuy Synthes biomaterials portfolio and joins the first generation Cellular Bone Matrix. Surgeons can now choose a preferred handling option based on the needs of each surgical case.

ViviGen Formable contains osteoinductive, demineralized fibers that create a putty-like consistency. The fibers interconnect to achieve the formable handling favored in open void cases such as posterolateral fusion, a common type of spinal fusion surgery. This unique handling helps surgeons mold the allograft into a defined shape, allowing ViviGen Formable to conform to the surgical site.

DePuy Synthes claims that both ViviGen and ViviGen Formable represent a paradigm shift in the field of bone repair by focusing on protecting viable, lineage committed bone cells from recovery to implantation while retaining all three properties required for bone formation, osteoinductivity, osteoconductivity and osteogenecity. ViviGen is now being used in a wide variety of trauma procedures for the repair or reconstruction of musculoskeletal defects.

ViviGen and ViviGen Formable are Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) comprised of cryopreserved, viable cells within a cortical cancellous bone matrix and demineralized bone. Over the past several years, LifeNet Health has conducted extensive research to enable the processing of these products to maintain cell viability, resulting in an acceptable alternative to autograft.

Physician comments

“ViviGen Formable has a great consistency, which allows it to be packed into the openings of the posterolateral spine,” said DePuy Synthes consultant Dr. Thomas Morrison, MD of Polaris Spine and Neurosurgery in Atlanta, Ga.

“The handling characteristics of ViviGen Formable deliver confidence that the fusion bed is well packed and grafted for fusion.”

**ViviGen Formable is regulated as an HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Product); pursuant to 21 CFR 1271

Source: DePuy Synthes


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