Pinnacle Spine Group Announces FDA Approval for the InFill® Direct Lateral System

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Pinnacle Spine Group (pinnaclespinegroup.com) finalizes a breakthrough procedure that allows Post-Implant Placement of Biologics, improving insertion and recovery time.

InFill system

InFill Direct Lateral System is FDA approved.

“Filling the device post implantation significantly improves the contact of the biologic
with the adjacent endplates, with the expectation that the increased contact will
promote more rapid bone healing.” - Russel W. Nelson M.D.

Pinnacle Spine Group, LLC, (“Pinnacle”) a Dallas, Texas-based company that designs, develops, manufactures and markets spinal implants and instruments, announces the FDA approval and market availability of its patented InFill® System for direct lateral spinal fusion procedures in treatment of various spinal pathologies. The System consists of the InFill® Interbody Fusion Device and InFill® Graft Delivery System.Together, the InFill® system allows precise placement of approved biologic material into an implanted device. This improves endplate engagement with the biologic as compared to that where the biologic is placed in the fusion device prior to implantation.

“It has long been a concern that biologic material packed into a fusion device prior to being implanted would not make optimal contact with the surfaces of typical of vertebral endplates”, explains Russell W. Nelson, M.D., Pinnacle’s Chief Medical Advisor. “Filling the device post implantation significantly improves the contact of the biologic with the adjacent endplates, with the expectation that the increased contact will promote more rapid bone healing.”

The InFill® System includes of an array of innovative lateral interbody fusion devices manufactured from PEEK-Optima®, and supplied in a sterile, single-use package. The implant is designed to provide a generous bone grafting area, with endplate contact surfaces that optimize the weight bearing properties of the cage. The Graft Delivery System is designed to facilitate controlled and precise placement of biologic material into the implanted device. Comprehensive instrumentation, including an innovative retractor system, extensive disc and endplate preparation options, and other specialized instrumentation to address the more challenging fusion levels complete the system.

Pinnacle Spine Group will be exhibiting at the North American Spine Society’s Annual Meeting in Dallas, October 24-27. Visit us at Booth 2543.

Visit us on the web at http://www.pinnaclespinegroup.com.

Pinnacle Spine Group was founded with the focused goal of developing innovative medical devices, conceived in the operating room, for surgical procedures of the spine. The objective for every device and instrument we develop is a better outcome for the patient, and a better experience for the surgeon and operating room staff.

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