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.
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.
