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Market Analysis

Hammertime: The Decade of the Hammertoe Implant

Plus AdvaMed's rep reentry rules, April's 510(k) clearances, and a Vantage TAR walkthrough.

Originally published May 20, 2020Integra · Medline

In this issue


Quick Hits | Decade of the Hammertoe Implant | Webinars

FAN Quick Hits

Vantage TAR Video

Exactech released an instructional surgical video of the Vantage Total Ankle Replacement. Victor Valderrabano MD, the design surgeon presenter, is based in Switzerland so this video is of the mobile bearing version. The mobile bearing poly is unavailable in the US, but the technique shown and the prosthesis are the same minus a poly lock component provided in the States.

FDA Device Clearances

Here is a list of the April FDA 510k Clearances for medical devices. There are over 40 orthopedic devices on the list and the 4 foot and ankle related clearances are shown below:

  • In2Bones - Colink CFX Plating System - The In2Bones CoLink®CfxPlating System is a system of plates and screws and surgical instruments intended for stabilization and fixation of calcaneal fractures and osteotomies.
  • Akros Surgical - Scruture Anchor Lis Franc System - Akros Scruture Anchor LisFranc Repair Kit is intended to provide fixation during the healing process following Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction).
  • Medshape - Dyna Clip - The MedShape DynaClipBone Staple is a sterile, single use orthopedic implant designed to use the principles of interference fit to hold the implant body into a predrilled hole and across the target fracture site.
  • MiRus, LLC - Atlas Plating System - The ATLAS™ Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies of small bones and bone fragments in adult and pediatric patients

ADVAMED Guidance

Advamed has issued Reentry Guidelines for Device Reps . Interesting to see that they are recommending the facility to provide the PPE for the reps. I wonder how long it will be before there is a vending machine at the hospital selling N95’s, face shields, and gowns in addition to the disposable scrubs ?

Integra Bilayer Wound Study

Integra LifeSciences announces positive clinical results and cost savings for Integra Bilayer Wound Matrix in wound healing studies. The data was published in Plastic and Reconstructive Surgery.

The first clinical publication shows 70% of the wounds successfully salvaged at the 180-day time-point, the authors were able to identify success factors across patient selection and wound types.

The second publication reviewed cost and resource utilization comparing Integra Bilayer Wound Matrix, Local Tissue Rearrangement (LTR) and Free Flap (FF). This study showed significantly longer surgery time at 85 and 408 minutes for LTR and FF respectively, compared with 50 minutes for Integra Bilayer Wound Matrix. It also reported more than double the length of stay in the hospital for both LTR and FF versus Integra Bilayer Wound Matrix. Lastly, total cost of the surgery was $53,492 for FF, $35,220 for LTR and $34,877 for Integra Bilayer Wound Matrix.

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Hammertime - The Decade of the Hammertoe Implant

The last 10 years could be described as the golden age of the intramedullary hammertoe device. Today, there are more hammertoe implants on the market than ever before. Every foot and ankle company markets at least one implant because the revenue opportunity is tremendous. With over a million performed annually and the $1000+ price tag it is easy math to understand why. According to Kenneth Research, the global Hammertoe Market was valued at USD 6.71 billion in 2016 and is projected to reach USD 14.12 billion by 2025.

The k-wire continues to be gold standard as it is simple and inexpensive but the drawbacks include pin tract infections and high rates of non union and malalignment. Surgeons have used cannulated screws, sutures, and staples in the past but companies have been trying to crack the code for over twenty years. As more distal extremity companies have come in to play the amount of implants has become exhaustive. We will review the major players in the space.

Stryker’s Smart Toe is still widely used and was brought to market in 2011. It was the first to use a memory metal and it is probably safe to say more have been implanted than any other design. They have since developed the Toe Tac Xpress , a PEEK implant with disposable cup/cone reamers.

Wright developed a silastic hammertoe, the Swanson, in the early 2000’s but to combat the Smart Toe they developed the Protoe VO which has been knocked off by many companies making small iterations to the Christmas tree middle phalinx fixation design. Through its multiple acquisitions Wright owns the original allograft implant, Tenfuse , and the Phalinx , which seems to be their front runner.

Zimmer/Biomet’s Nextra implant is a two piece implant with multiple options and special reamers. Gramedica has recently followed suit with a two piece Opti-toe implant but the first was the now defunct Stayfuse, developed by Tornier in 2008.

Arthrex is best known for its absorbable Trim-it pins . Their first metal implant, Retrofusion , was very similar to Wright’s Protoe C2 but their most recent implant, Dynanite , is claimed to be the first cannulated Nitinol implant.

Paragon28 developed the Hammertube , a PEEK tube coated with porous titanium plasma spray. And they are the first to address the hammertoe with a novel soft tissue fixation implant, the TenoTac .

While all of these work time will tell which works better than others. We believe MIS will be the next chapter in hammertoe surgery sometimes requiring no fixation at all.

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Upcoming Corporate Webinars

What are you feeling like this week??

Thursday night has a nice offering of MIS Bunions (Wright), Hindfoot (APMA), or Midfoot (Medline UNITE).

Attention Companies! Please let us know where we can find the replays for those who can't watch live. We will post them here and on the website.

Webinars listed by date/time.

Artelon - Peroneal Challenges and Novel Solutions

Wednesday – May 20 @ 8pm ET

Speakers: Dr. Daniel Cuttica DO, Dr. Steven Neufeld MD, and Dr. Mark A Prissel DPM

REGISTER HERE

AOFAS - The Troublesome Triad: Knee Trauma, Peroneal Nerve Injuries, and Foot Drop – The Team Approach

Wednesday – May 20th @ 9pm ET

Faculty: Christopher Dy, MD; Jeffrey E. Johnson, MD; Susan Mackinnon, MD; Matthew Matava, MD

Faculty from the American Orthopaedic Foot & Ankle Society (AOFAS), the American Orthopaedic Society for Sports Medicine (AOSSM), and the American Society for Surgery of the Hand (ASSH), will provide multi-subspecialty perspectives in a case-based framework to describe the current management of knee trauma, the peroneal nerve injury, and the treatment techniques for foot drop.

REGISTER HERE

GRECMIP - MIS Postoperative Care and Complications

Thursday May 21st, 2020 10 AM EST

Speakers:

Pablo Sotelano (ARG)

Frederick Michels (BEL)

Georg Hochheuser (GER)

REGISTER HERE

Medline UNITE - Novel Indications for Midfoot/Hindfoot Procedures,

Thursday - May 21st @ 8pm ET

Speakers: Scott Shawen, MD and John Lewis, MD

REGISTER HERE

Wright Medical - MICA MIS Bunion Procedure

Thursday – May 21st @ 8pm ET

Speakers – Dr. Hodges Davis, MD and Peter Mangone, MD

PROstep™ Minimally Invasive Surgery Live Webinar. The second of the series takes a detailed look at the PROstep™ MICA™ MIS bunion procedure for hallux valgus deformity with HV case review and discussion.

REGISTER HERE

NEMO HEALTH - Essential Adaptations: Post Covid19 Business Survival Strategies

Wednesday - May 20 @ 8pm ET

Speakers: Dr. John Guiliana and Dr. Jeff Frederick

REGISTER HERE

APMA - Medial Double Arthrodesis and Flatfoot Reconstruction

Thursday – May 21st @ 8pm ET

Speaker –Jon Goldsmith, DPM

REGISTER HERE

ACELL - Limb Salvage with Severe Gas Gangrene

Thursday - May 21st @ 3pm ET

Speaker - Dr. Sammy Eghbalieh, MD

Join our upcoming webinar with vascular surgeon Dr. Sammy Eghbalieh, who will describe treatment of a patient presenting with severe gas gangrene to the lower extremity. Dr. Eghbalieh will share his experiences using an extracellular matrix technology (MicroMatrix® and Cytal® Wound Matrix) to manage the complex wound following initial surgical debridement to provide coverage of exposed tendons and preserve extremity length.

REGISTER HERE

WBCT Society - Clinical Research & Innovations

Saturday - May 23rd @ 10am ET - 4pm ET

Speakers - 20 Speakers - view AGENDA

The International WBCT Society, an independent group which promotes dialogue and collaboration around weight-bearing CT research, announced a day-long webinar event on Saturday, May 23, 9 a.m. – 3 p.m. CT. Split into five topic sessions, the webinar will feature talks from 20 experts on WBCT imaging. The panels will each be moderated by a Society board member, and panelists hail from North America and Europe.

REGISTER HERE

FORWARD TO FRIENDS/COLLEAGUES AND SHARE!

If you have an upcoming webinar or event you would like to promote, please contact us a t footandanklenews@gmail.com

Or if you have an article you would like to share, please email it to us at footandanklenews@gmail.com


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