Providing a New Cellular Allograft with Alternative Consistency for Spinal Fusion Surgery
Bone graft substitute comprised of viable, lineage committed bone cells
delivers all three properties required for bone formation
RAYNHAM, Mass. – February 13, 2017 – Today, DePuy Synthes*, in collaboration with LifeNet Health®, launches ViviGen Formable™ Cellular Bone Matrix**, a second generation cellular allograft used to assist in the formation of bone during spinal fusion surgery. ViviGen Formable augments the DePuy Synthes biomaterials portfolio and joins the first generation, ViviGen® Cellular Bone Matrix, which launched in late 2014. With both ViviGen and ViviGen Formable, surgeons may now choose a preferred handling option based on the needs of each surgical case.
ViviGen Formable containsosteoinductive, demineralized fibers that create a putty-like consistency. The fibers interconnectto 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.
“ViviGen Formable has a great consistency, which allows it to be packed into the openings of the posterolateral spine,” said 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.”
Both ViviGen and ViviGen Formable represent a paradigm shift in the field of bone repair by focusing onprotecting 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 areHuman 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 autograft1.
DePuy Synthes has an exclusive worldwide agreement to market and promote ViviGen and ViviGen Formable.
About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.
*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its subsidiaries.
**ViviGen Formable is regulated as an HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Product); pursuant to 21 CFR 1271.
***Consultant to DePuy Synthes Spine
ViviGen and ViviGen Formable are trademarks of LifeNet Health
1. Data on File LifeNet HealthDHF 12-008, DHF 15-001
DSUS/MOC/0117/0662(1) 2/17 EX-17-008