Salto XT – Revision Ankle Replacement System

Screen Shot: Foot Innovate - revision of a failed ankle replacement: replacement or arthrodesis

Screen Shot: Foot Innovate – revision of a failed ankle replacement: replacement or arthrodesis

If you have not watched the latest Foot Innovate web cast featuring Dr. Mark Myerson, watch it now.  Dr. Myerson reviews his options for revision ankle replacement surgery and how he decides to treat each case based on certain patient specific factors:

  • good range of motion = replacement prosthesis
  • chronic pain = fusion
  • poor bone quality = fusion
  • medical co-morbidities = cement spacer
  • need for early ambulation = replacement prosthesis

The webinar covers his entire revision armamentarium which includes ankle arthroplasty prosthesis, ankle fusions with anterior plating, TTC fusions nails, as well as some effective uses of antibiotic cement spacers. In addition to a variety of case examples, Dr. Myerson also gave us a sneak peak into the new Salto XT revision prosthesis.  The revision components were developed by a team of surgeons lead by  Dr. Myerson and Dr. Chris Coetzee. According to Dr. Myerson, the Salto XT is currently available in Europe on a limited release basis.

Screen Shot:  Foot Innovate - revision of a failed ankle replacement: replacement or arthodesis

Screen Shot: Foot Innovate – revision of a failed ankle replacement: replacement or arthrodesis

The system includes:

  • 3 Tibial Sizes
  • Intramedullary 40mm Keel
  • Same tibial base plate from the Salto Talarius
  • Posterior talar augments to address subsidence
  • Long stem talar components
Screen Shot: Foot Innovate - revision of a failed ankle replacement: replacement or arthrodesis

Screen Shot: Foot Innovate – revision of a failed ankle replacement: replacement or arthrodesis

While Dr. Myerson did not say when he thought these products would be available in the US, he eluded to the fact that US surgeons would only have access to the posterior augments.  With first generation replacements like the Agility failing, revision components are needed.  Nice work by Tornier on being ahead of the curve.  It will be interesting to see when the FDA will approve these new components for use in the US and when Wright Medical will follow with revision components of there own.

Uh Oh…FDA rejects Wright Medical’s PMA for Augment!

Wright Logo

BioMimeticlogo

Wright Medical issued a press release announcing that they received a not approvable letter from the FDA on their PMA application for Augment Bone Graft.  Needless to say, Wright has got to be pissed…and confused.

In the letter, FDA states it is “concerned that the population enrolled was predominantly low risk and, therefore, may not have warranted the use of either autograft or Augment Bone Graft.” FDA went on to state it believes that “it will be necessary to perform a new clinical study that evaluates the use of Augment Bone Graft as a substitute for autograft in hindfoot and ankle fusion procedures in a well-defined high-risk target population, where the use of autograft would be clinically warranted.”

In summary, FDA concerns included “the patient population studied in the clinical study, the amount of graft material implanted, and the uncertainty as to whether any graft material would be needed or if the use of no graft material in a fusion procedure of the hindfoot and ankle in the population studied would have achieved similar results.” FDA provided a number of additional observations about the clinical study design and results.

Wright announced plans on November 19, 2012 to acquire BioMimetic Therapeutics, Inc. for an upfront purchase price of approximately $190 million in cash and stock plus additional milestone payments of up to approximately $190 million in cash, which are payable upon receipt of FDA approval of Augment Bone Graft and upon achieving certain revenue milestones.

BioMimetic’s Augment product line is based on recombinant human platelet-derived growth factor (rhPDGF-BB), a synthetic copy of one of the body’s principal healing agents. In June 2012, BioMimetic submitted a responsive PMA amendment responding to FDA’s request for additional information about the product.  Wright has been waiting it’s approval and most insiders were assuming it was a foregone conclusion.  Not the case I guess.

In the July 3rd, 2013 issue of JBJS, “the study” (Recombinant Human Platelet-Derived Growth Factor-BB and Beta-Tricalcium Phosphate (rhPDGF-BB/β-TCP): An Alternative to Autogenous Bone Graft) comprised of 494 patents from 37 test sites determined that: patients requiring hindfoot or ankle arthrodesis, treatment with rhPDGF-BB/β-TCP resulted in comparable fusion rates, less pain, and fewer side effects as compared with treatment with autograft.  This study involved some of the biggest names in the foot and ankle world, lead by Brown University’s Christopher DiGiovanni MD. A link to the abstract can be found here.

Where does Wright Medical go from here and who is to blame?  Medtronics Infuse?  How will this impact Wright Medical moving forward? Wright Medical just sold off its total joint line to the Chinese based MicroPort to become a stand alone foot and ankle and biologics company.  Did this rejection put an end to a possible behind the scenes acquisition deal from a larger player like Stryker, Smith and Nephew, or Zimmer?  The positive is that 3 days ago, Wright reported a 29% growth in foot and ankle.  Hopefully this news does not drastically derail plans moving forward.  Looks like It’s back to the drawing board in Memphis, hopefully Bob P and the gang figure something out soon or the purchase of BioMimetics could go down as the “Sam Bowie” or “A-ROD contract” or “New Coke” of medical acquisitions.

Any comments, product release news, or tips…hit us up at footandankleblog@gmail.com

Foot Innovate Webinar Reminder – Ankle Fusion Plating

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Tonight is a great opportunity to get some insight on Ankle Fusion plating from Orthocarolina’s Dr. Carrol Jones.  If you are a Wright rep, learn about your system from one of the designers.  If you are competitor, learn about the different approaches available to fuse an ankle and determine the strengths and weaknesses of your competitors system.

You will need to register at least 15 minutes prior to the webinar.  Go to http://www.footinnovate.com to reserve your spot.

Wright Medical Ankle Fusion Plating System

Topic:        Ankle Fusion Plating Systems

Presenter:  Carroll Jones, MD

Date:         Wednesday, July 31, 2013

Time:         8:00 pm, Eastern Daylight Time

AOFAS 2013 – Surgical Implant Choice

AOFAS 2013

Dr. William C. McGarvey gave an interesting talk (Advances in Midfoot Fixation: Technology Review) to wrap up the pre-meeting session on why and how docs should choose their implants.

The list stated was as follows:

  1. Cost
  2. Bulk
  3. Time
  4. Effectiveness
  5. Return to Activity

The lecture went through the evolution of the ‘gold standards’ of midfoot arthrodesis hardware based on the literature starting with cannulated screws vs plantar plating, then dorsal plating, then intramedualary fixation (IO Fix), then locked plating, etc. It was very interesting and an extremely well put together talk citing the chronological history of literature reported for the last 20 plus years. The above list is something all reps should think about prior to walking into their next sales call.

#6 and #7 reasons doctors use what they use…

In my opinion, there are two additional factors that play into in the decision making process of almost all foot and ankle surgeons:

#6 – Consulting agreements

Granted, doctors with consulting agreements are a small percentage of the population, however it can be argued that they influence what their colleagues who respect them choose to use based on there published or unpublished outcomes.  When a doctor travels to an Industry course and a prominent surgeon tells them a product works, they will give it a chance.

# 7 – Rep Relationship

Doctors want to work with people they like, they want a rep to knows their shit, and most importantly be reliable. When a case is going on a rep should have everything that the doc asked for and additional products they didn’t ask for, but may need. If a doc knows a rep has his back, he will go with that relationship over cost in my experience.

Implant cost is going to be a constant topic of conversation. The question of implant companies over-charging vs R&D for future technology is going to come to a head sooner rather than later.  While I am no where near as smart as Dr. McGarvey, industry influences still play a roll and I am sure he would not disagree.  The real question moving forward is for how long?

Wanna sell this?

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The Metric Staple is a nitinol compression staple with a “grenade pin” that needs to be pulled prior to final impaction.  While the grenade action failed to impress and the impaction device had some fiddle factor, the outcome looked good. The staple comes in various sizes and can be used for a variety of indications.  Wanna add this staple line to your bag?  Hit us up at footandankleblog@gmail.com.

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New Product Release AOFAS Summer Meeting (PART 2)

SBI logo

  • A3 Fusion Nail - TTC Fusion nail with a double distal bend, one posterior and one lateral. The nail also has a “Compression Bolt” which is appears to be an internal compression screw.  A TTC fusion nail is a great salvage procedure for failed Total Ankle Replacement, this is a great move for SBI.  Hopefully, this launch is not a reflection on the 5 year outcomes of their STAR Total Ankle Replacement.

Wright Logo

  • 3DI Ankle Fusion Plating System - The “Leader in Foot and Ankle Surgery” has released a four plate style system using Wrights 3DI Poly Axial Ortholoc Technology, in doing so filling a major void in the Wright product line.  Plating for ankle fusions is trending upwards vs screws which should translate to positive growth for Wright in the near future.  Wright also soft launched a new, low-profile total ankle replacement to compete with STAR and Salto.  Look for a future posts about the full release of Wright’s Infinity Total Ankle System

Zimmer logo

  • NORMED – Zimmer rolled out the Normed product line in all of its glory. Nothing too exciting, but this acquisition shows that Zimmer is making its move into the foot and ankle market. Zimmer’s lateral approach Trabecular Metal Total Ankle, launched earlier this year also drew interest being the newest TAR prosthesis on the market.