France and Germany, get ready…FH Orthopedics, developer of the Elastic Spine Prosthesis (ESP), is on its way to a hospital near you. The company has recently signed two new agreements, one with France Rachis and the other with Via 4 Spine in Germany.
FH Orthopedics: New European Distribution Agreements
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Eric Hermann, FH Orthopedics’ Spine Business Unit Director, said in the July 21, 2015 news release, “These two agents have the best profiles to promote the ESP disc ranges as they both strongly believe in non-fusion solutions, they are already working with spine surgeons, the prostheses fit perfectly their current portfolio without any conflict with existing business, and they are active nationwide.”
France Rachis (FR2D or French Spine Distribution & Development) has its own spine-focused sales force of five representatives who specialize in non-fusion solutions. Via 4 Spine, with a network of six sales representatives in Germany, will market FH Orthopedics’ LP-ESP and CP-ESP.
According to the news release, “The LP-ESP is indicated for lumbar discopathy that is resistant to medical treatment, lumbar discopathy disease after treatment of a herniated disc, and radiculopathy by a recurrence of a disc hernia (except for excluded hernias). Patients implanted with the LP-ESP showed significant improvement in VAS and OSWESTRY scores of 75% and 74%, respectively.”
“The LP-ESP has nine years of clinical experience; the CP-ESP for cervical applications is available in heights from 5mm to 7mm with three different footprints. Both devices provide up to six degrees of freedom: flexion, extension, right and left bending, axial rotation, and translation. In addition, they offer an adaptive center of rotation and improved stability. These latest generation intervertebral disc replacements offer greater shock absorption and automatic return versus traditional disc replacements using ball and socket technology. The ESP discs are also non-surface-bearing for increased life of the devices and have been tested up to 40 million cycles.”
Hermann told OTW, “Both distributors were given the instruction to find, train and help start new surgeons to use the ESP disc prosthesis. They both got product trainings by our team and fortunately our mono bloc disc design meets great interest from surgeons and patients.”
“For next year, we are looking to expand to UK and Spain and other countries outside of Europe.”
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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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