Amplitude Surgical, of Valence, France, the leading French manufacturer of hip and knee implants, with more than 50, 000 implants inserted every year, is now in America.
French Manufacturer of Implants Arrives—Welcome Amplitude Surgical!
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Earlier this year the company received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for its Anatomic implant, a device that addresses degenerative knee disorders.
Company Chairman and CEO Olivier Jallabert said, “This is a major milestone for Amplitude Surgical; it rewards the work of an entire team, from creative surgeons to engineers. Our Anatomic® knee has been a real success, with more than 20, 000 surgeries carried out to date.”
“This clearance provides us with access to the U.S. market, worth over 4 billion dollars. It illustrates the high quality of our implant, which is unquestionably suited to American standards, and will enable our U.S. subsidiary, Amplitude Orthopedics Corp., to launch its commercial activity.”
With a market share of close to 15% in knee implants, the company ranks no. 2 in France. It is just behind Zimmer Biomet and well ahead of the other major international players such as DePuy (J&J), Stryker or Smith & Nephew.
The company was founded in 1997 in Valence, France. Amplitude Surgical became a leading French player on the global surgical technology market for lower-limb orthopedics. The company develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery.
Amplitude Surgical develops numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents.
The company operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. Amplitude Surgical distributes its products in more than 30 countries. At June 30, 2016, Amplitude Surgical had a workforce of almost 300 employees and recorded sales of over 80 million euros.
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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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