Expanding Cage presented at ISASS ahead of US and EU regulatory clearances

FLXfit_2_jpgEXPANDING ORTHOPEDICS’ CAGE PRESENTED AT ISASS (Orthopedics This Week)

Expanding Orthopedics Inc. (EOI) is pleased to announce that the FLXfit, TLIF 3D expandable cage will be presented for the first time at the prestigious annual meeting of the International Society for the Advancement of Spine Surgery (ISASS) in Miami. Professor Jean Charles Le Huec will present the work performed with his international colleagues, Dr. Klaus Schnake and Dr. Ory Keynan.

In the April 29, 2014 news release, Professor Le Huec, Head, Ortho-Spine Department, Bordeaux University Hospital, France, former president of ISASS and EuroSpine, explained that “correcting anatomical balance in the lumbar spine is imperative, particularly in the lower disc spaces. The current cages available on the market have limited possibilities for lordosis correction and are sometimes difficult to maneuver. In addition, the contact between the implant and endplate is not always optimal, leading to improper stability after the surgery.”

Dr. Keynan, head of Service for Degenerative and Age-Related Spinal Disorders at the Sourasky Medical Center, Tel-Aviv, Israel, noted that “the FLXfit addresses the need for a wide anterior footprint coverage. The design allows a minimal invasive, uni-lateral TLIF approach and its articulated self-guidance feature enables a smooth introduction and an optimal placement after expansion. The lordotic expansion facilitates the lordosis correction at the treated level.”

Dr. Schnake, head of the Spine Surgery Center at the Nurenberg Schoen Klinik, Germany, added that “the FLXfit successfully passed all relevant international biomechanical testing, with equivalent or superior results compared to alternative devices in all measures. In cadaver studies performed with my colleagues, all cages were successfully implanted, positioned and expanded with a steep learning curve. Reversibility of the expansion for easy and safe intra-op removal was successfully validated. Lordosis restoration was evaluated at each level and the implant/endplate contact showed good results.”

Professor Le Huec, concluded that “initial biomechanical and cadaver testing shows that the FLXfit is a unique three-dimensional expandable articulated TLIF cage that meets the requirements of strength, stability, anatomical benefits and user-friendliness. It combines the benefits of minimal invasive access, optimal footprint, large bone graft chamber, press fit insertion and adaptability to the patients’ anatomy while allowing an optimal lordosis restoration.”

Ofer Bokobza, CEO of Expanding Orthopedics, told OTW, “EOI is currently in the midst of CE and FDA approval processes. The device is getting great feedback from surgeons due to its unique design and ease of use. Once cleared, EOI will be starting clinical use of the FLXfit device in selected centers in Europe and later in the U.S. EOI is also planning to release few additional unique cages based on our 3D expanding technology platform.”

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