From Abbott:

Dear Patients:

As you may be aware, Abbott Diabetes Care has been experiencing a supply interruption in the United States with the FreeStyle Navigator® Continuous Glucose Monitoring System. This interruption has affected our ability to provide U.S. patients with new system kits or warranty replacement components.

We are committed to producing high quality, safe and effective products and to providing the best possible customer service. When we bring a product to market, it is our responsibility to consistently provide the product to customers. In the U.S. we have not been able to consistently supply the Freestyle Navigator System to patients.

As a result, Abbott is permanently discontinuing the FreeStyle Navigator System in the U.S. We understand this decision may affect how some patients manage their blood glucose and we have several options available to help FreeStyle Navigator System patients in the U.S. transition to alternative glucose monitoring technologies.

The discontinuation of the FreeStyle Navigator System in the U.S. is not for safety reasons. The System is safe and effective and continues to be available to patients in seven other markets outside the U.S. No other Abbott Diabetes Care or FreeStyle products are affected by this discontinuation.

The discontinuation of the FreeStyle Navigator System in the U.S. will be conducted in an orderly manner and Abbott will provide U.S. customers with options available through March 2012 that can help with the transition to alternative products. Customers who wish to learn about the available options should contact Abbott Diabetes Care customer service at 1- 800-221-7700 for assistance.

We know FreeStyle Navigator System customers in the U.S. have lived with some uncertainty and frustration. We are grateful for the commitment patients and providers have devoted to the FreeStyle Navigator System over the years, and we are sorry that we have been unable to consistently meet their needs.

ADC remains committed to glucose monitoring and to developing other highly innovative glucose monitoring products based on the sensing technology that is at the heart of the FreeStyle Navigator System.


Link to update on Abbott's web site:
http://www.abbottdiabetescare.com/adc_dotcom/url/content/en_US/gene...

Tags: CGM, abbott, freestyle, navigator

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It does not make any sense at all that a supply interruption permanently affects U.S. customers only and customers outside the U.S. will not be affected. It would have been easy for Abbott to fabricate a better lie. I wonder whether this press release is the work of a disgruntled employee who strives to alienate Abbott customers.
Helmut, Abbott deserves your smackdown but I am sad because people raved about its accuracy. On the positive side, Dexcom does not appear to be resting on its laurels and are already looking to development beyond the G4.
Does it frustrate anyone else to see a company so heavily invested in "future" technology when they've essentially been at a standstill with the FDA for over a year with the product they're currently trying to bring to market?

It's already available in Europe... I sincerely doubt we'll see the Dex G4 here before they've developed something "better".
Well said, Helmut. My father used to say to me, "Don't p*** in my ear and tell me it's raining." I say the same to Abbott. It will be a cold day in hell before I patronize them if there is any alternative. You claim to care about the disruption to the lives of Navigator users. You care so little that you can't even bother to provide a reason that a fourth-grader would believe. And then you compound the insult by touting your "commitment" to developing other products based on this technology.
Here's my take, from afar, based on a bit of experience in the corporate world... Somebody screwed up badly and wants this all to go away. Heads should roll; no doubt rather they will get promoted, as all who are complicit in this snafu share the same desire to evade responsibility.
Abbott, take my FreeStyle Navigator and sensors back, send me the money, and then sit down hard on them.
LOL, it is really strange. The navigator will be available to patients in seven other markets but not in the U.S.? It seems like they are having problems to get approval by the FDA for the new navigator models.
I think you are right, the real reason has to do with the FDA and Abbott made the situation worse with clumsy PR.
Thanks for letting us know, Manny.
That sucks. Mine is out of warranty.
I will have to see what they offer as "an available option," if anything.
The available option is the same as the last time $2000 for the unit and $125 for the sensors. there is no other option from them. I had to ask to have my case "escalated" to get this "confirmation" The money can be spent on a unit in France or Israel, the UK system is mmols, not mg/dl as in the USA. Seveal people, and the outside units are seeing if import is possible from these companies, but FDA import rules would apply.. It is not the FDA that caoused the shutdown of the abbot USA navigator, but good old licensing rights.
What did Charlton Heston say about guns? You can pry it from my cold dead fingers, or something like that. I am certainly pissed off (can we say that here?), but the Navigator is so much better than anything else in the US. I bought my replacement Navigator overseas, which was certainly a hassle, but well worth it, in my opinion. The sensors, I could get in the US. I am going to stock up on sensors and keep going as long as I can. If anyone has any practical ideas about getting sensors in the US from one of the 7 lucky countries, please post it here. We can probably get them, but insurance or lack of insurance, may make it too expensive.
John, I am one of the lucky still being able to use the Nav because Iive in London. One of the main differences from Dex is the distance/ range you get with the Nav an the accuracy arond the hypo levels. Let me know if I can help.

Gos

It's close on 2 1/2 years since this was announced and us USians find ourselves left with a choice of Medtronic CGMs (which are effectively tied to Medtronic pumps) or Dexcom CGMs.

That's not a lot of choice.

At the time Abbott blamed "supply" problems (see the previous 2011 posts) but it is inconceivable that supply, or manufacturing, problems will hold a product back in one of the worlds major markets when that same product continues to be manufactured and supplied in the other major markets.

Elsewhere (http://integrateddiabetes.com/Articles/cgm/cgm%20comparisons%20for%... [diatribe]) "cost/reimbursement" problems were blamed. But this year the whole cost/reimbursement scene in the US changed with the introduction of many more insurance companies to the diabetic market. (I.e. insurance companies that, prior to Jan 1 2014, simply didn't cover diabetics.)

And in other places it is suggested that there were licensing issues with the original developer of the sensor Abbott was using.

Meanwhile it is clear that Abbott continues to market the FreeStyle Navigator II everywhere but the US and that the price is comparable with the Dexcom G4.

Does anyone have any idea about what is going on?

John Bowler

Abbott UK has this to say:

"Unfortunately FreeStyle Navigator II is not available in USA at the moment. If you would like to know if and eventually when it will be introduced in USA please contact our helpline in USA on (888) 522-5226."

Unfortunately the US number doesn't work - there's no way for me to avoid getting told about some major recall and then having the phone hung up (their voice response system is American speakers only!)

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