FDA Clears Foundation Surgical's Vertiwedge® Intraosseous System for Vertebral Body Replacement
核心洞察
The FDA has granted 510(k) clearance to Foundation Surgical (搜索)'s Vertiwedge® Intraosseous System (搜索), a novel device for partial vertebral body replacement in the thoracolumbar spine.
Indicated for use in T1-L5, the device addresses conditions like trauma, fractures, tumors (搜索), and degenerative spine disease (搜索) by restoring vertebral height.
The Vertiwedge® system facilitates vertebral body correction via the VBO® procedure, preserving spinal motion without requiring intervertebral fusion.
The U.S. Food and Drug Administration (FDA) has cleared Foundation Surgical (搜索) Group, Inc.'s Vertiwedge® Intraosseous System (搜索), a novel spinal vertebral body replacement device. This clearance allows for the partial replacement of a diseased or damaged vertebral body, marking a significant advancement in spine surgery.
The Vertiwedge® Intraosseous System (搜索) is indicated for use in the thoracolumbar spine (T1-L5). It addresses conditions such as previous trauma (fracture), tumors (搜索), or degenerative spine disease (搜索). The device is designed to replace a portion and/or restore the height of a collapsed vertebral body following resection or excision.
Innovative Vertebral Body Osteotomy (VBO®) Procedure
According to Foundation Surgical (搜索) CEO Dr. Randal Betz, the Vertiwedge® clearance and the launch of the VBO® procedure represent "a new era of spine surgery." The VBO® procedure is a novel, single-position, motion-sparing technique that allows for effective treatment through a conventional lateral or oblique lateral approach. This facilitates indirect decompression of the nerve roots while preserving the natural motion of the disc and facet joints, eliminating the need for intervertebral fusion.
The FDA stipulates that the system should be placed within the vertebral body following an osteotomy. It must be supplemented with autograft or allograft and used with its contralateral staple. If fewer than the maximum number of screws are used, supplemental fixation is required to augment stability.
Restoring Spinal Integrity
Foundation Surgical (搜索)'s Vertiwedge® is also intended to restore the integrity of the spinal column, even without fusion, in patients with advanced-stage tumors (搜索) involving the thoracolumbar spine. This is particularly relevant when the patient's life expectancy is insufficient to permit the achievement of fusion.
The Vertiwedge® obtained 510(k) clearance by demonstrating substantial equivalence to the PILLAR SA PEEK Spacer System, manufactured by Blackstone Medical, Inc. (acquired by Orthofix International NV in 2006).
According to Foundation Surgical (搜索), the Vertiwedge® is the first intraosseous device designed to facilitate and maintain vertebral body correction of partially collapsed vertebrae via the VBO® procedure.