Where will Salto go???

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Per the FTC, the merger between Wright Medical and Tornier cannot happen until the Salto Talaris Total Ankle is divested from the new companies portfolio.  What looked like a great pick up for the Wright Medical extremity reps turns out to be a total bust in terms of snagging some easy ankle business.  Now the question becomes who will buy it and more importantly who can Wright sell it to without shooting themselves in the foot by strengthening a competitor.  This is no easy task and the management team at Wright is going to have to pull the trigger soon.

So where is it going to land?  Let’s look at the contenders:

Zimmer/Biomet – Zimmer obviously has the TM lateral ankle and Biomet is due to launch there own ankle sometime in the 4th quarter of 2015.  With their own deal still not done I cannot see this as a need or something with in the realm of possibility.  The odds of a purchase = Not on the radar. No Chance!

Stryker – With the recent purchase of SBI and the S.T.A.R ankle it does not seem feasible or make any sense for this to happen.  How would the FTC allow them to carry two ankles if that is the reason they are making Wright dump it?  Bottom line, it won’t happen.

Arthrex – Never known for acquisitions this doesn’t seem like something in Reinhold’s wheelhouse.  Do not see this as a priority for the team down in Naples.  From a Wright perspective, this would be equivalent to arming Afghanistan. Yes they need to dump it to get the deal done, but Arthrex would be the last place I would sell it if I were Wright.  With that being said, it may be a possibility.

Depuy/Synthes – With the Agility retired the Salto may fit nicely in their bag.  There are probably some remaining dinosaur reps who previously covered agility who could jump right in and start covering the ankles.  They have the cash and this could really help fortify there extremity bag.

Smith and Nephew – With a Stryker deal seemingly not happening anytime soon why not grab a total ankle and make a serious push in extremities.  If nothing else, it would give a charge to the trauma/extremity team with a solid ankle to continue to build around.I would say this Memphis

Bottom line is that this is a no win situation for Wright Medical from a foot and ankle perspective.  They are going to have to sell this prosthesis to someone and hope the Infinity will continue to gobble market share.

We have Failed…

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to keep you informed on the happenings in the world of foot and ankle.  We are sorry for that but…We’re baaaackk!!!!

After a short 18 month sabbatical, Foot and Ankle Blog is ready to churn out some more content for the sorry shleps like us who actually care about this stuff.

We look forward to relaying industry info, new product news, academic reviews and much more.  If you have anything you would like to talk about, contact us at footandankleblog@gmail.com.

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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