Nextremity Solutions, Inc. has announced that its latest proprietary forefoot surgery system, the MSP Metatarsal Shortening Plate and System, has received FDA clearance and CE Mark certification. The MSP system is positioned for metatarsal shortening osteotomies to correct toe angulation/dislocation and relieve pressure. It provides the company with a product candidate in another key segment of forefoot surgery. The company will prepare for a limited product release in the coming weeks.
Nextremity: FDA Clearance, CE Mark for Forefoot System
1 min read Premium comments
Secondary
In the May 27, 2014 news release, Nextremity President and CEO Rod K. Mayer, remarked, “We are very pleased to obtain key regulatory approvals for MSP so soon after last month’s Re+Line launch. Initial surgeon feedback on MSP is that we have achieved an important innovation for forefoot surgery. This is encouraging as we expand our product portfolio.”
Lon S. Weiner, M.D., chief of orthopedic trauma at Lenox Hill Hospital in New York, explained, “The MSP plate is designed to provide a greater level of precision and repeatability because the osteotomy guide and metatarsal reduction/control have been engineered into the implant. We enthusiastically await the clinical experience of our surgeon colleagues.”
Judith F. Baumhauer, M.D., M.P.H., professor, Department of Orthopaedic Surgery, Foot and Ankle Division, University of Rochester commented, “Based on my cadaver lab experience with MSP, I believe that the plate’s control of metatarsal segments will provide for a more stable and precise fixation. It has the makings of a game changer product.”
Rod Mayer told OTW, “Once again we are excited to take another step forward in advancing techniques that will address unmet clinical needs in forefoot surgery. Based upon initial cadaver labs and feedback from our Surgeon Advisory Board, we are confident that we have developed a game-changing technology that will address the concerns expressed by foot and ankle surgeons with current techniques and their clinical results. We look forward to our national and global launch of this product at the completion of our BETA evaluation, which begins in mid-July 2014.”
React:
Discussion
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.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.