The first surgical case using K2M Group Holdings, Inc.’s CAPRI Corpectomy Cage System has been completed.
First Surgery Using K2M’s Corpectomy Cage Reported
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The company announced on December 22, 2014 that Stefano Boriani, M.D., at Rizzoli Hospital in Bologna, Italy performed the surgery using the expandable vertebral body replacement device. The device provides structural stability following a corpectomy or vertebrectomy.
“Continuous Height Expansion and Endplate Angulation”
Dr. Boriani said the system offers surgeons a “truly innovative cage system that is designed to allow for continuous height expansion and endplate angulation. Due to this unique design and functionality, I was able to adjust the cage in-situ to engage the patient’s inferior and superior vertebral body endplates. I am very pleased with the design, functionality and ease of use.”
The cages, manufactured from titanium and cobalt chrome, are offered “in a variety of interchangeable footprint options, allowing for in-situ height expansion and endplate angulation to match the patient’s anatomy. Additionally, the device may be implanted through an anterior, lateral or posterior approach.”
Intended Uses and Regulatory Clearances
The company statement says the cage is intended “for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The system is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.”
“A corpectomy is a surgical procedure to remove a vertebral body, usually to decompress the spinal cord.” In this surgery, according to Spine-Health, “the vertebral bodies and adjacent vertebral discs are removed in order to alleviate the pressure on the spinal cord, which is causing spinal stenosis and cervical myelopathy. A bone graft is then inserted into the space to allow for a fusion of the bone segments into one long bone.” Vertebrectomy is the surgical excision of a vertebra.
K2M President and CEO Eric Major said this “milestone” reinforces the company’s commitment to establishing itself as the “global leader in providing solutions for complex spinal pathologies.”
The company received 510(k) clearance from the FDA for the system in November and can now sell the system in the U.S. The company also said it recently received Europe’s CE Mark for the device.
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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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