Scottsdale, AZ – November 8, 2024–Foundation Surgical, an innovative leader in spinal implant technology, is thrilled to announce the US Food & Drug Administration (FDA) 510(k) clearance of its Vertiwedge® Intraosseous Device! This novel, motion-sparing partial vertebral body replacement device along with its Vertebral Body Osteotomy (VBO®) procedure is set to redefine the landscape of lateral and motion sparing spinal procedures.The Vertiwedge® is the first intraosseous device designed to facilitate and maintain vertebral body correction of partially collapsed vertebrae via the groundbreaking VBO® procedure.
This novel single-position, motion-sparing technique, allows for effective treatment through a conventional lateral or oblique lateral approach and facilitates indirect decompression of the nerve roots while preserving the natural motion of the disc and facet joints without the need for intervertebral fusion.
“With the FDA clearance of the Vertiwedge® and the launch of the VBO® procedure, we are ushering in a new era of spine surgery,” said Dr. Randal Betz, founder and CEO of Foundation Surgical. “Our approach allows for the treatment of degenerative conditions while preserving the spine’s natural motion, a significant step forward in patient care.”
The Vertiwedge® and VBO® stand alongside Foundation Surgical’s earlier innovation, the single-position lateral LLIF180™ procedure, which debuted with the FDA clearance of the Interwedge® Standalone Lateral Interbody Fusion Device. This latest advancement marks another milestone in the company’s commitment to pioneering transformative surgical techniques. For more information about the Vertiwedge® Intraosseous Device and the motion-sparing VBO® technique, please refer to the Vertiwedge® Indications for Use or reach out to us directly.
Join us in celebrating this significant breakthrough in spinal health!
Visit http://www.foundationsurgical.com or contact us at info@foundationsurgical.com for more details.
About Foundation Surgical
Foundation Surgical is an innovative spine implant company, leading the way in developing novel spine procedures. Founded by renowned deformity spine surgeon Dr. Randal Betz and experienced spinal device engineer Dale Whipple, the company is committed to developing state-of-the-art surgical solutions to transform the lives of patients with spinal conditions.
Contact:
Asher Breverman
Director of Product & Marketing
Foundation Surgical
abreverman@foundationsurgical.com
(727) 209-7436
Disclaimer: This press release contains forward-looking statements about Foundation Surgicals future initiatives and performance, which involve risks and uncertainties. Actual results may differ materially from those projected.