Navigator dead in the US Options

[tedm]

http://www.abbottdiabetescare.com/adc_dotc...nt_0000422.html

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.

I can't say I'm surprised. Probably the FDA. Just one more Diabetes device not available in the USA. (IMG:style_emoticons/default/badmood.gif)

[Linda B]

I am so worried that the same thing will happen with the Enlite sensor from MM. It is SO frustrating that they have been available for a long time in Europe and we still don't have them.
Especially when the reason is that the pump will indicate a sensor end at 3 days but the enlite works for 6. We are all using the current sensors for at least 6 anyway! Sometimes the FDA just does not make sense

Linda B.

[Mike G]

I am so worried that the same thing will happen with the Enlite sensor from MM. It is SO frustrating that they have been available for a long time in Europe and we still don't have them.
Especially when the reason is that the pump will indicate a sensor end at 3 days but the enlite works for 6. We are all using the current sensors for at least 6 anyway! Sometimes the FDA just does not make sense

Linda B.

Couldn't MM just relabel Enlite for 3 days for the US? From what I have read here the sensors may be more accurate, more comfortable, etc. More than just extended duration. Aren't the old sensors approved for 6 days in Europe and 3 here?? I understand the issue with the pump software but it seems to me there is a way around this if MM wanted.

[Aaron]

I am so worried that the same thing will happen with the Enlite sensor from MM. It is SO frustrating that they have been available for a long time in Europe and we still don't have them.
Especially when the reason is that the pump will indicate a sensor end at 3 days but the enlite works for 6. We are all using the current sensors for at least 6 anyway! Sometimes the FDA just does not make sense

The Enlite sensor isn't available in Canada yet either; we don't have the sensor end at 3 days - it works for six. However, Health Canada can be very slow with the approval process and Medtronic isn't forthcoming about what may be available until after they have been approved. I do expect that the Enlite sensor will eventually be available in Canada but I don't expect it to happen for about a year yet (seeing as the VEO was available in Europe for more than a year before Health Canada approved it).