Whatever Happened to… Abbott’s Navigator?

Speaking of CGM that’s not ready for prime-time, what the heck is the hold-up on Abbott’s FreeStyle Navigator, the third continuous glucose monitoring product originally expected to hit the market last year?Navigator_q

In a statement posted last month, the company’s website says only: “Abbott’s FreeStyle
Continuous Glucose Monitoring System was launched in Europe last year
and is under active U.S. FDA review. Also in development is a fully integrated
blood glucose monitoring system combining a meter, test strips and lancing
capabilities in one device.”

That second bit sounds intriguing. But no sense holding our breath for a combo device from a company whose CGM has been stalled at the FDA approval stage for ages. What could be holding it up, I wonder? Especially since I hear that
technology-wise, the Navigator may be “the best of the bunch.”

Turns out that David Kliff, D-analyst extraordinaire of Diabetic Investor, was on this just as my curiosity was peaking. He tells me that a number of fumbles on Abbott’s side are at fault, beginning with insisting on an approval for “replacement” therapy vs. the less-aggressive “adjunct” therapy approval that DexCom and Medtronic were able to secure. This means the FDA was OK with approving those CGMs as an addition to, rather than a replacement for, traditional fingerstick glucose monitoring. On top of that, Abbott apparently made a few moves that angered the FDA.

Wow, to think that petty politics might be involved in holding up an otherwise valuable medical device!

Anyway, Kliff is pretty sure that Abbott’s not going to meet their latest approval deadline, either — the end of this quarter, which is coming up fast. And he’s sarcastic about it. Check out this little “quiz” emailed to his subscriber base a few days ago (reprinted with his permission):

1. Do you believe Navigator will be approved by the end of the first quarter? Yes No

2. The company will miss another stated dated for approval. True False

3. To save face the company will find another company to file an intellectual property lawsuit against. True False

4. The Navigator will get approval before the end of the first quarter. True False

5. After approval the company will announce they’ve decided not to launch the product in its present configuration and will launch an updated version later in the year. True False

“Perhaps a better question to ask is whether there is any chance for Navigator commercially,” Kliff writes. “Diabetic Investor sees Abbott Diabetes Care at the crossroads. Their conventional glucose monitoring business continues to lose share, they lack a coherent strategy to regain share and the Navigator, even if approved, will do little to help. Using history as a guide, Abbott would try to buy their way out of their problems. Given the current landscape in blood glucose monitoring their choices are limited, there is no Therasense to save the day. The company could go after Home Diagnostics or privately held AgaMatrix but after seeing what they did to Therasense, why would either company want to be acquired by a company with a proven history of turning gold into sand?

Ouch. In contradiction to its name, Navigator doesn’t seem to be heading in the right direction (?)


10 Responses

  1. Dave Cartier
    Dave Cartier February 22, 2008 at 7:03 am | | Reply

    While we are on the subject whatever happened to the non-invasive glucose sensor that was supposed to surprise us by being out by last Christmas?

  2. MoHo
    MoHo February 22, 2008 at 7:15 am | | Reply

    What about companies like Living Cell Tech. that is supposed to come out with coated pig islets? I read that there are a couple of companies doing that kind of work, have they all gone the way of the Navigator?
    This is bad news about Navigator, all talk was that this was to be the gold standard in a market that is in dire need of user friendliness and reliability.
    Another great post, thanks Amy.

  3. ~andrew
    ~andrew February 22, 2008 at 10:29 am | | Reply

    I once read that Abbott was developing a monitor device that used an implanted sensor just under the skin. The monitor would power the sensor wirelessly when in close proximity – simply holding the monitor over the sensor site. The sensor would send back the ready. Now, that would be cool! 1 please.

  4. George
    George February 22, 2008 at 12:05 pm | | Reply

    If Abbott is such a bad company, why did Smith’s Medical partner with Abbott on the Cozmonitor, and Omnipod partner with Abbott on their monitor??
    Both the Cozmonitor and the Omnipod seem to be working well with Abbott technology.

  5. Mark Summers
    Mark Summers February 23, 2008 at 6:53 am | | Reply

    You say that Navigator has launched in Europe, but I have not seen it for sale anywhere, with or without a prescription. Is it really available for use outside of controlled experiments?

  6. Dan Golan
    Dan Golan February 24, 2008 at 6:36 am | | Reply

    I don’t know if this is correct but what I heard is that the FDA has issue with the safety of the reagent that is used by the navigator sensor.

  7. Kevin D.
    Kevin D. February 24, 2008 at 12:36 pm | | Reply

    Mark…The Navigator was approved in Europe by their equivalent of the FDA last summer. If it’s available or not, that I’m not sure. Basically, it would be like the FDA approving it here. It can be sold, but if they aren’t producing it or are producing it at such a low quantity, it may not be widely available. They may also be waiting on FDA approval so they have it in America and can produce it on a large scale.

  8. joren
    joren February 26, 2008 at 6:43 am | | Reply

    the problem in europe is not the licence they need from our goverments. it’s the insurace company that refuses to pay for this system

    in holland the meter wil set you back a €750,- and every strip around €55,-

    there is a law that says a insurance company has to pay for a pomp if needed but not for a realtime measuring systems like the navigator.
    Even if the person is impossible to set whith a pomp

  9. Steve
    Steve February 29, 2008 at 3:34 am | | Reply

    Thanks for the information. You mentioned Abbott losing market share. An interesting article would give some detail on the conventional glucose testing meter market. A chart would display which products increased/decreased share of the past few years.

  10. jacki
    jacki July 2, 2008 at 8:20 am | | Reply

    My son is wearing a Navigator and it is GREAT!

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