Parsippany, New Jersey-based Extremity Medical, LLC’s Omni MTP Fusion System has been cleared for sale in the U.S. by the FDA. The FDA took just a little over three months to clear the device.
Extremity Medical Foot Fusion System Cleared
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The company’s Chairman and CEO is Matt Lyons, one of the founders of Blackstone Medical, Inc. in 1996. Lyons cofounded Extremity Medical in 2008 with Jamy Gannoe. Other senior managers at the company also came from Blackstone Medical.
Metatarsophalangeal Fusion System
According to a November 9, 2017 company press release, the Omni system is a “comprehensive MTP (metatarsophalangeal) fusion system which provides all traditionally used methods for fixation of the MTP joint for fusion.”
The metatarsophalangeal joints are the joints between the metatarsal bones of the foot and the proximal bones (proximal phalanges) of the toes.
The system made up of plates, screws and posts, uses the company’s patent pending PlantarFiX technology. The company says the technology is a modular component designed specifically to generate consistent plantar-side compression across the arthrodesis site regardless of patient bone quality.
Lyons said the Omni system, along with the Axis Charcot Fixation System, and the BioFuse- Viable Bone Graft launches in 2017, “demonstrates Extremity Medical’s focus and dedication to continue to develop innovative products that will significantly impact the extremity surgeon’s ability to treat challenging patient conditions. These innovative designs will do just that.”
Initial cases with the system were expected to take place in mid-November.
The company has 17 products released globally which include “specialized fixation and advanced” arthroplasty systems for the distal lower and upper extremities. The company has also been issued 19 patents with an additional 16 patents pending for its core product technology.
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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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