FDAnews Device Daily Bulletin

Ellipse Technologies’ Precice2 Limb Lengthening System Wins FDA Clearance

Feb. 6, 2014

Ellipse Technologies said Tuesday that the FDA has cleared its next-generation Precice2 Intramedullary Limb Lengthening System for use in femurs and tibias shortened by congenital conditions or post-traumatic fractures.

Originally cleared for marketing in 2011, the Precice system involves an implanted intramedullary nail that interacts magnetically with an external remote control. Implantation of the upgraded Precice2 has been simplified by a nonmodular intramedullary design that increases nail length and distraction range options. It also adds a smaller 8.5 mm diameter for patients whose anatomy is too small to be compatible with the 2011 system.

“The big key is more sizes,” Ellipse CEO Ed Roschak told Device Daily Bulletin. “With Precice1, we had a 12.5 mm diameter and a 10.7 mm and those were good for adults and maybe some older adolescents or pediatrics, but we really needed a small device to treat in the eight- to 12-year-old range, and that we can do now with our 8.5 mm device.”

Ellipse expects to complete its U.S. launch of Precice2 in the second quarter of this year. The system is CE-marked in the EU and authorized for marketing in South Korea. It is available in Australia and New Zealand for compassionate use. Ellipse is working on clearance in South American countries such as Argentina and Colombia as well, Roschak said, with Brazil following later. — Lena Freund

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