FDA Approves Medicrea's Cervical Compression Staple
Spinal surgery implant maker Medicrea said Friday it received FDA approval for the K-Jaws cervical compression staple for all cervical fixation indications carried out with interbody cages.
According to Denys Sournac, CEO of the Lyon, France, company, the approved indications are the same indications as those for cervical plates. He called the approval process “the longest and most complex we have ever had to administer with the FDA.”
However, compared with cervical plates, the K-Jaws implant is less-invasive and much quicker to implant, Medicrea maintains. The surgeon fixes two adjacent vertebrae by compression around an interbody cage, which results in greater stability, the company adds.
Approximately 5,000 units have been implanted since 2006, when the product launched outside the U.S. Medicrea’s K-Jaws staple targets an estimated $1.2 billion cervical fixation market currently dominated by cervical plates and standalone cage ranges.
Medicrea is exploring whether to distribute the implant to a potential base of 5,000 U.S. surgeons through an outside company or via an expanded U.S. distribution subsidiary. — Kellen Owings
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