K2M Group Holdings, Inc. (Nasdaq:KTWO) (the “Company†or “K2Mâ€), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced the completion of the first surgical case using the Company’s CAPRIâ„¢ Corpectomy Cage System, an expandable vertebral body replacement device that provides structural stability following a corpectomy or vertebrectomy. The first surgical case was performed by Dr. Stefano Boriani at Rizzoli Hospital in Bologna, Italy.
“The CAPRI Corpectomy Cage offers surgeons a truly innovative cage system that is designed to allow for continuous height expansion and endplate angulation,†said Dr. Boriani. “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.â€
The CAPRI Corpectomy Cage System 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.
CAPRI 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.
“We are pleased to announce the successful completion of the first surgical case using CAPRI,†stated Eric Major, K2M’s President and CEO. “This milestone reinforces K2M’s commitment to establishing ourselves as the global leader in providing solutions for complex spinal pathologies.â€
On Nov. 12, K2M announced it had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market CAPRI in the United States. The Company also recently received the CE Mark to expand the Company’s global distribution of the product.
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