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Issue Date: April 28, 2022 |
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ANNOUNCEMENTS
FAN is back after a spring break hiatus, hitting your inbox with some new product launches this week. The foot and ankle market is as interesting as ever and this week the soft tissue battle, specifically the syndesmosis market, is going to take center stage.
A reader note: While we have not taken any money from anyone in terms of advertising or paid content creation ever, we are giving you all a heads up we are close to selling-out. A few companies who have been badgering us for weeks will be making creative paid appearances. The ads will be obvious, and we will never sell out our journalistic integrity (if you even consider this journalism) when it comes to the promotion of device reviews and opinions.
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Thank you very much for reading, we are extremely grateful for all of our FAN's!
Sincerely,
Big Foot
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This week we have:
- Golden Sawbone of the Week - Social Media
- Syndesmosis Market - FAN Quick Take
- Access Past FAN Newsletters
- PodiatryMeetings.com Calendar of Events
- AOFAS Meetings Updated Listing
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GOLDEN SAWBONE OF THE WEEK
Social Media Edition
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This week’s winner has an Instagram account that is full of trauma disasters, complex foot reconstructions, and the occasional Florida sunshine shot.
Congrats to Dr. Alan MacGill, DPM for winning this week’s Golden Sawbone Award.
View his page HERE and give him a follow if you dig it like we do!
His FEATURED POST involves a revision of a trimalleolar ankle fracture, thanks for the explanation and rational. Great work!
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Follow FAN on LinkedIn!
https://www.linkedin.com/company/footandanklenews/
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SYNDESMOSIS MARKET - QUICK TAKE |
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Arthrex is the far and away leader when it comes to the lucrative $150 million + syndesmosis market. The reason for this is quite simple – the market has been created and driven by data. Suture button fixation was once a novelty, not so much anymore. There are multiple level 1, randomized controlled studies with 5-year follow-up that show the malreduction rate, re-operation rate, and hardware failures are significantly lower when using the Arthrex Tightrope versus screw fixation. The tightrope has been proven to be durable and literature shows that using a tightrope can assist in helping the fibula find its home in obtaining proper anatomic reduction. Here is a recent OTA Podcast reviewing the Evolution of Syndesmotic Fixation.
So, we all know that Arthrex created this market, and they have the literature to back-up their product. They are currently on their 3rd generation of the tightrope. When you are the king of the mountain, competitors will be looming to take a bite out of the market and there are quite a few available today.
Here is a quick list of some syndesmosis devices available on the market today:
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Suture Screw:
Why all this syndesmosis talk? Well, this week our new product launches begin with a new syndesmosis device from the Purple Guys out West. Let’s take a look at the R3ACT product launch and a couple other recent product announcements from Paragon28 and Medline.
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The new Paragon syndesmotic device
is an upgrade to their novel break off screw technology R3LEASE, which was designed to hold rigid fixation during the critical healing period of the syndesmosis and it was intentionally notched so the screw would break in the clear space once motion returned. This product concept was then reengineered to include an internal suture. The idea is similar to that of Synthes Fibulink, the difference being that it starts with rigid fixation across all four cortices, and once motion returns and the screw breaks, the internal suture will potentially maintain reduction and allow micromotion of the syndesmosis. This seems to make some sense and to give them credit, it is not a “me too” version of suture button constructs we listed above.
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The immediate concern, again like the Fibulink construct, is the obvious revision and/or removal concerns down the line along with surgeon placement and reduction concerns. Syndesmotic screws have been shown in studies by top traumatologists to have a malreduction rate of up to 40% and the implantation of this device is still a screw. So, while the rigidity argument may make sense for some people, if implanted incorrectly at the time of surgery will the suture constraint aspect of the device cause more problems than a traditional broken screw? I am not smart enough to know the answer to that, and time will tell if this device can compete with traditional suture button fixation, now considered the current gold standard by most. Regardless, Paragon 28 now has another novel option in their bag to offer surgeons looking for an alternative. They keep pumping stuff out, kudos to P28! |
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Paragon takes another shot across the bow of the soft tissue kings down in Naples with their Paratrooper Plantar Plate Repair System. The system is touted as an all-suture repair that can be approached from plantar or dorsal. There is no links to any surgical techniques to this product quite yet, but it appears to take a simple approach to a tough problem where usable tissue for repair is often times not found. This product adds to P28’s hammertoe repair line which also includes the Teno Tak and Hammer Tube.
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Medline
Medline is adding to its foot and ankle bag this week with some extensions in trauma and sports medicine. Nothing revolutionary, but solid product fillers to complete their line which will allow them to stand next to anyone in terms of breath of portfolio. Medline continues to chip away and add the must-have “me too” products. We expect the team at Medline to eventually breakout some unique, game changing technology over the course of the next few years to help them standout and potentially be a target for acquisition if management decides the Unite Foot and Ankle Line makes sense to move.
The long time privately held Medline, founded in 1966, was recently purchased in 2021 by private equity for 34 BILLION! They are known for their leadership role in the hospital disposables market, and if one division does not mesh with the core competency of the business, it would be the Unite Foot and Ankle line. Medline could thrive under a new umbrella that better understands the orthopedic market and would potentially provide more resources to fuel innovation.
Speculation is great, isn’t it?
Here are their new products:
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Dexten is an interference screw line created for the foot and ankle with sizes ranging from 4.5 to 7mm all with a length of 15mm. We included a technique video of an FHL transfer done by Kent Ellington, MD from Ortho Carolina.
DEXTEN™ Tenodesis Screws are made from PEEK. Available implant diameters and lengths are ideal for common tendon transfers in foot & ankle surgery, such as FDL and FHL tendon transfers. The system comes equipped with a suture loop to whipstitch tendons, a tendon sizer, Ø2.4 x 240mm suture guide drill pins, acorn reamers, and a hex driver.
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Calc Fracture Plates
Again, the calc fracture plates are not going to change the way surgeons deal with these often times life changing fractures. However, the line is complete offering three different plate styles with accompanying instruments to handle all fracture patterns. The addition of fully threaded large frag screws rounds out the set.
The system is comprised of multiple implant options, including standard, offset, and extension Sinus Tarsi and Perimeter plates, as well as new, large fully threaded 5.5mm and 7.0mm headed cannulated screws. The system also comes equipped with a Sinus Tarsi Extension Plate Inserter, allowing for easy plate insertion and positioning through a sinus tarsi incision, enabling percutaneous screw placement in the posterior tuberosity.
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IM Ankle FX Screws
Hold off on opening the pelvis set! Medline has you covered by adding 3.5 screws long enough to traverse any fracture when intramedullary fixation is needed.
"Unlike a traditional screw, the implant features a special tapered diameter designed specifically to fit within the fibula canal, and a dual-lead thread for faster insertion," said Dr. Scott B. Shawen, MD of Charlotte, N.C. "It's also available in lengths ranging from 65 – 150mm and comes standard in the tray, so our hospital and OR staff can avoid the excess cost and inefficiency of needing to locate and pull a separate tray with extra-long screws, such as a pelvic fracture set."
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PodiatryMeetings.com Calendar
Looking for a meeting?
This resource has an extensive amount of information for meeting opportunities where you can earn your required continuing education credits.
Click below to access the extensive meeting calendar.
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AOFAS Upcoming Meetings & Courses |
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July 7-9, 2022
September 14-17, 2022 | Québec City, Canada
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About Foot and Ankle News & Contact Information
Foot and Ankle News is curated roundup of the most impactful news for Foot and Ankle Doctors, Rep’s, and Exec’s delivered weekly directly to your inbox.
- Breaking News
- Device Technology
- Journal Reviews
- Upcoming Events
- Practice Advice
All of our posts from our weekly email newsletter can be found at www.footandanklenews.com. Our newsletter goes out to over 12,000 foot and ankle surgeons and industry professionals across the country. The articles are created by a group of volunteers and freelance industry insiders. If you you would like to contact us or have an article or topic you would like to share, please submit it to: footandanklenews@gmail.com
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