Zimmer Biomet Holdings, Inc. finished its coming out party at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting with announcements of a deal to distribute CelgenTek Innovations Corp’s bone trauma technology and launches of the Persona Medial Congruent Bearing and OsseoTi Tibial Sleeves for the Vanguard 360 Revision Knee System.
Zimmer Biomet/CelgenTek Deal and New Launches at AAOS
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CelgenTek Innovations Distribution Agreement
On March 4, 2016, the company announced an exclusive global distribution agreement with CelgenTek Innovations Corporation, which includes its N-Force Fixation System and iN3 Cement. The bone void-filling solution, according to the announcement, allows for the direct administration of Zimmer Biomet’s N-Force Blue-Bone Substitute Material (BSM) (available in the U.S.) and CelgenTek’s iN3 Cement (available in the European Union-EU) directly through a fenestrated screw in a single integrated construct.
CelgenTek Innovations, comprised of subsidiaries InnoVision, Inc., Memphis, Tennessee, and CelgenTek, LTD, Shannon, Ireland, designs and manufactures the N-Force Fixation System and iN3 Cement. The N-Force Fixation System is an augmented fixation system cleared in the U.S. and EU and the iN3 is a pre-mix calcium phosphate cement available in the EU.
Randy Sessler, vice president and general manager of Zimmer Biomet’s global trauma business, said the company chose to pursue this partnership because adding CelgenTek’s products to the company’s trauma portfolio equips surgeons with “exceptional tools that can unlock personalized outcome for patients.”
The financial terms of the transaction were not disclosed.
Persona Medial Congruent Bearing
The Persona Medial Congruent Bearing complements the company’s flagship Persona, The Personalized Knee System. The bearing, according to a March 3, 2016 press release, is designed to recreate a more natural feeling motion of the human knee by maximizing knee joint stability throughout the full range of motion. “Engineered from studies of the morphology and kinematics of a natural, healthy knee, the Persona Medial Congruent Bearing represents the convergence of Zimmer Biomet’s ultracongruent designs with personalized femoral components, ” stated the company announcement.
OsseoTi Tibial Sleeves
The OsseoTi Tibial Sleeves, according to the company, complement the Vanguard 360 Revision Knee System by addressing a wide range of cavitary defects commonly encountered in revision knee procedures. Based on a typical highly vascularized metaphyseal region of the tibia, these sleeves feature the company’s proprietary OsseoTi porous metal technology, and are designed to distribute the load through biologic fixation from the tibial plateau and stem to loads closer to the joint. “Made of a cutting edge technology by printing the metal and porous structure together, it creates a truly unified three-dimensional porous homogenous construct that mimics cancellous bone architecture and modulus.”
The sleeves offer a wide variety of sizing and positioning options, and can be used separately, together or in conjunction with a block augment. The sleeves are designed to be positioned independently or symmetrically within the tibia, resulting in a bone-conserving solution for addressing cavitary defects.
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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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