Reading, PA – September 8, 2025 – Foundation Surgical today announced the successful completion of the first-ever surgical case using its newly FDA-cleared Interwedge® Standalone Lateral implant system. The procedure was performed by Dr. Edward DelSole at Reading Hospital in Reading, Pennsylvania, part of the Tower Health healthcare system.
Foundation Surgical Announces First-Ever Surgery Using the Interwedge® Standalone Lateral Implant System
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The Interwedge® Standalone Lateral system is designed to provide surgeons with a versatile and stable standalone option for lateral interbody fusion procedures, addressing both the clinical demands of complex cases and the evolving needs of patients.
Dr. DelSole remarked on the significance of the device in his first experience with it:
“I think the Foundation Surgical Interwedge® is going to be the new standard in lateral interbody fusion. It provides state-of-the-art anterior column fixation with the novel staple technology. I think it’s going to make the standalone lateral lumbar surgery much safer and more reliable.”
The procedure represents an important milestone for Foundation Surgical as it transitions its products from regulatory clearance into real-world clinical adoption.
Dr. Randal Betz, Founder and CEO of Foundation Surgical, commented:
“This is an incredibly exciting milestone for our company. Seeing the Interwedge® Standalone Lateral successfully used in the operating room validates years of development and reinforces our mission to bring meaningful advancements to spine surgery. We are proud to support surgeons like Dr. DelSole who are committed to improving patient outcomes.”
With the first clinical use of the Interwedge® completed, Foundation Surgical is moving forward with its alpha launch program, partnering with select surgeons and hospitals across the U.S. to expand clinical adoption of the system.
About Foundation Surgical
Foundation Surgical is a spine implant manufacturer committed to advancing motion preservation and lateral surgery. The company is developing a portfolio of innovative solutions, including the Interwedge® Standalone Lateral fusion system and the Vertiwedge® motion-sparing intraosseous device for the novel Vertebral Body Osteotomy (VBO®) procedure. Founded by world-renowned deformity surgeon Randal Betz, MD, Foundation Surgical’s mission is to provide surgeons and patients with better treatment options that preserve motion, restore function, and improve quality of life.
Media Contact:
Asher Breverman
Director of Product & Marketing
Foundation Surgical
abreverman@foundationsurgical.com
(727) 209-7436
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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