Article preview from Start-Up - May, 2012
Cutting Edge Spine LLC has adopted a “less material” and “more open” engineering design philosophy to create its E-Vol family of interbody spacers. The start-up aims to offer implants that provide maximum bone/bone interface, loading and structural support and stability, to become a functional, integral part of the spine.
Article preview from Start-Up - May, 2012
Before founding Cutting Edge Spine LLC in 2009, spine industry veteran Randy Roof had become increasingly frustrated by the interbody spacers he sold. During spinal fusion, these spacers offer structural support to the spine between two vertebrae and help restore spinal balance. The permanent implants also facilitate the growth of bone afterwards.
“As an exclusive agent for a number of orthopedic firms, I was dismayed with interbody spacers from a design perspective,” Roof recalls. “Although I felt the material was often 100% correct for the application, many of the designs, in my opinion, were not complementary to what should have been the absolute and final objective: providing optimal stability, load sharing and fusion results. Many of the surgeons within my territory of coverage shared the frustration and I had a strong feeling that surgeons, patients and hospitals could use a better solution.”
Thus was borne Cutting Edge Spine (CES). In April 2011, the company received 510(k) clearance for E-Vol (evolutionary), a family of five interbody spacers. Roof estimates that the potential annual US market opportunity for E-Vol is over $1 billion, entailing tens of thousands of spinal fusion procedures. CE mark is expected within the next 12 months.
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