San Antonio, Texas-based Nvision Biomedical Technologies, Inc. has unveiled its PEEK-OPTIMA HA Enhanced in Lapidus and Subtalar Fusion Wedges, making them the fifth and sixth medical devices cleared by Nvision utilizing PEEK-OPTIMA HA Enhanced.
First Lapidus Wedge With an FDA Lengthening Reference, Launched
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According to the company, it is the first Lapidus and Subtalar Fusion Wedge implant to obtain a specific lengthening reference in its FDA indication.
According to Nvision’s Senior Vice President of Product Development, Tom Zink, “Most Lapidus procedures shorten the first array to some extent. The Trigon Lapidus Wedge System restores the natural anatomy which restores the natural function of the first array. The ability to restore the natural length can be beneficial in revision cases and also in a primary fusion because it prevents possible secondary issues due to the loss of length.”
“We are always looking at new ways to address different foot and ankle procedures that will benefit the patient and surgeon,” said Zink. “By taking an innovative approach to marrying the best materials, manufacturing platforms, and engineering science, we are changing the conversation around foot and ankle surgery.”
When OTW asked Zink how the PEEK-OPTIMA HA Enhanced promotes multi-directional bone healing and enhances fixation, he noted, “The ability of the Trigon Lapidus Wedge to correct in both the sagittal and transverse planes promotes the bone to heal in the proper alignment of the first array.”
“The Trigon Lapidus Wedge is a PEEK-OPTIMA HA Enhanced implant indicated for a first metatarsal-cuneiform lengthening arthrodesis. It is offered in three footprint sizes with various length restoring thicknesses, as well as variations in sagittal and transverse angle correction. Additionally, the system provides a jig that allows for frontal plane rotation, resulting in triplanar correction with the ability to restore or maintain length of the first metatarsal.”
“The Trigon Stand-Alone Subtalar Wedge is the first PEEK-OPTIMA HA Enhanced wedge for Subtalar Fusion in the market. The PEEK-OPTIMA HA Enhanced material, which has a modulus similar to bone, allows artifact-free imaging and provides an osteoconductive surface for bone ongrowth. With a 25mm diameter, the Subtalar Wedge offers correction heights ranging from 6mm to 16mm in parallel and angled options.”
Zink added, “Surgeons have been taught to have bone to bone contact for the best chance at fusion. The PEEK HA Enhanced material of the Trigon Lapidus Wedge System promotes osteointegration so the bone can fuse completely through and around the wedge. The nature of the material and design promote fast healing and less loss of natural function for the patient.”
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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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