New product introductions and innovative technologies set the stage for AOFAS 2021.
At the American Orthopaedic Foot & Ankle Society (AOFAS) meeting in Charlotte, NC, SmartTRAK identified several key themes and takeaways from the meeting as manufacturers showcased innovation through new product introductions, continue to focus on hallux valgus corrections and the associated instrumentation allowing for reproducible outcomes and the advancements of 3D printed solutions.
The Luster of New Products Help Drive Healthy Foot & Ankle Competition
The foot & ankle space does not look like it is slowing down anytime soon based on the products highlighted at AOFAS. Innovation is helping to drive growth in the US market for Foot & Ankle Repair and Reconstruction, which is projected to reach a 5-year CAGR of +4.9% according to SmartTRAK’s Foot & Ankle Market Overview. Newsworthy highlights include:
- Stryker* launched its Citrelock Tendon Fixation Device System at AOFAS. The new system provides surgeons a differentiated design featuring a resorbable technology, known as Citregen. Also showcased was the Wright Medical and legacy Stryker foot & ankle solution portfolio which includes the T2 ICF Nailing System*, VariAx 2 plating system* and the Ortholoc 2 LapiFuse Triplanar correction system.
- DePuy Synthes* pushed the Fibulink Syndesmosis Repair System* holding surgeon led symposiums discussing the benefit of the new product introduction. The Fibulink is positioned as advantageous to screws that have been found to result in screw breakage, loss of reduction and patient pain. The Fibulink is a flexible device like suture buttons, but does not result in occasional creep/slack that suture buttons can experience according to surgeon discussions.
- Paragon 28* focused on their APEX 3D Total Ankle Replacement System* with the MAVEN patient-Specific Instrumentation. Also highlighted out of Paragon 28’s robust foot & ankle fixation portfolio was the new Silverback Span Plating System*, the newest addition to the Silverback Ankle Fusion Plating System. The new Span Plating System includes posterior and anterior plates for use when a significant void is present at the ankle joint and/or talus. Immediately following AOFAS, the foot & ankle powerhouse filed with the SEC to raise up to $100MM in an IPO. The company plans to list on the NYSE under the symbol FNA. Paragon 28 had filed confidentially on August 2, 2021.
- Orthofix focuses on Charcot foot as they pull together existing solutions as well as a new product introduction, SOLE Medial Column Fusion Plate*, under the SOLE Charcot Foot & Ankle Portfolio of Solutions. The portfolio also includes existing Charcot solutions such as the G-Beam Fusion Beaming System*, Ankle Hindfoot Nailing System*, TL-Hex TrueLok Hexapod System* and TrueLok*. SmartTRAK anticipates the Company will continue to focus on Charcot with additional new product releases.
- Arthex’s Primary Pilon Fusion Plating System*, designed to treat distal tibia fractures that require not only fracture reduction but also primary ankle arthrodesis, includes an Anterolateral Pilon/Tibiotalar Fusion Plate as well as a Posterior Pilon/Tibiotalar Fusion Plate Design. The Company also displayed its new Kreulock locking compression screws* with internal Arthrex testing showing up to 22+ lb of additional compression vs. regular compression screws. Arthrex made a move into the trauma world with the trochanteric IM Nail System, a next-gen hip nail that includes the feature of a telescoping lag screw. The foot & ankle player is rounding out its trauma assortment with new IM Nailing product entries to hit the market. Offering a full portfolio to customers appears to be the goal for the Company, which at one time was a predominantly extremities-focused competitor.
Hallux Valgus Corrections Take Center Stage
At AOFAS, Treace Medical showcased their new release, Adductoplasty that includes instruments and fixation implants for midfoot deformity corrections. Leveraging their impact on the Foot & Ankle Segment with the Lapiplasty System, Adductoplasty offers cut guides to support surgeons when correcting challenging midfoot pathologies.
Crossroads Extremities featured their DynaBunion 4D Lapidus System, a take on 3D bunion corrections, as Crossroads noted the 4th dimension is the compressive nature of the nitinol plate. Crossroads also revealed their new minimally-invasive (MIS) miniBunion 3D™ System* with Viking Instrumentation for bunion repair. The system enables surgeons to restore toe alignment in three dimensions through a small incision on the side of the foot that is virtually hidden from patient view. Additionally, MIS bunion surgery allows patients to have a walking recovery.
Arthrex, who currently offers MIS options, is also looking to provide an MIS all in one guide, allowing surgeons a precise targeting tool when inserting headless screws. The guide allows for reproducible corrections compared to freehand incisions and screw insertion. The MIS trend continues to grow in line with patient satisfaction rates and reduced recovery time and is a movement SmartTRAK will continue to monitor.
Spotlight on 3D Printing
There was lots of chatter at AOFAS 2021 surrounding 3D printing, from patient-specific total talus implants to generic 3D-printed screws and k-wires. While total talus implants have been around for a while, initially ceramic in material, the entry of 3D-printing technology has resulted in an evolution of how total talus implants can be developed and implanted. During the Innovation in Orthopedics Symposium, surgeons discussed the revived interest in total talus attributing the interest to failure and revisions of total ankle replacement implants. 3D printing offers the opportunity to recreate the talus. Utilizing 3D printing for the talus allows for a customized implant that can be complicated and intricate in design based upon a patient’s personalized anatomical needs. Continuing to gather post-op data is important to determine when and how these implants may fail and what the revision surgery will look like. So while this area is exciting, researchers and clinicians continue to examine this ongoing shift in care.
Customized 3D printing is not the only option, multiple conversations at AOFAS revolved around the idea of offering 3D-printed generic, off the shelf implants such as wedges, screws, k-wires, etc. Companies such as restor3D, known for patient-specific, 3D-printed implants and recently merged with Kinos Medical, is focusing on offering these off the shelf items in the future.
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