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Home/Company News/FH Orthopedics’ Spine Business Is Now Spine Innovations
Company News

FH Orthopedics’ Spine Business Is Now Spine Innovations

October 15, 2020 1 min read Premium comments

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FH Orthopedics’ Spine Business Is Now Spine Innovations
Spine Innovations SAS
Secondary#fhrotho#spineinnovations

Spine Innovations SAS will take over the spine business of FH Ortho SAS, a French orthopedic device company with subsidiaries in the U.S., UK, and Poland. The company announced in a recent press release that the decisions was due to the growing demand for the ESP disc replacement devices, which constituted the entirety of FH Ortho’s spine business.

The new subsidiary will continue to be based in Heimsbrunn, a town in north-eastern France. FH Ortho will continue to produce and market devices for shoulder, knee, and extremity surgery.

The ESP, which stands for “elastic spine pad,” is CE marked and available in the EU and other geographies that allow CE marked devices, such as Australia. It consists of titanium endplates with hydroxyapatite coating which sandwich a deformable, elastomeric core. The core of the cervical disc is made of a polycarbonate urethane (PCU), while the lumbar disc contains a PCU annulus, and a silicone inner core. The semi constrained disc replacement has been available for lumbar disc replacement with the LP-ESP® since 2006 and for cervical disc replacement with the CP-ESP® since 2012. The discs allow for 6 degrees of motion with ranges that mimic the natural capabilities of a healthy disc.

" data-large-file="https://i0.wp.com/ryortho.com/wp-content/uploads/2020/10/FHOrthopedics_CPESPandLPESP_WEB.jpg?fit=850%2C425&ssl=1" src="https://i0.wp.com/ryortho.com/wp-content/uploads/2020/10/FHOrthopedics_CPESPandLPESP_WEB.jpg?resize=850%2C425&ssl=1" alt="" width="850" height="425">
CP-ESP and LP-ESP

The ESP discs were developed over the course of a 10-year collaboration between Hôpital Pitié Salpêtrière in Paris, the French Atomic Energy Commission (CEA) and the Université Paris VI as part of the Oséo Innovation contest. FH Ortho established a dedicated spine business unit in 2014 to market the devices to 12 countries globally. The company estimates implantation of over 26,000 devices annually.

Spine Innovations officially launched October 1, 2020. The devices are not FDA approved, and the company has not disclosed any efforts to bring the ESP disc replacement devices to the U.S. However, the company’s U.S subsidiary, FH ORTHO, Inc., markets and sells its shoulder arthroplasty, knee ligament repair and MIS foot surgery solutions domestically.

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

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?

8
JT
James Thornton, MDSpine Fellow · HSS

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.

5
RP
R. PatelSports Medicine · Stanford

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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