There has been a lot of confusion this past week about what the heck is going on with the next-generation, not-yet-to-market Medtronic Enlite CGM sensors. And it's perfectly understandable — it was confusing!

But guess what? The Enlite sensor has just received CE (Conformité Européenne) Mark approval in France, and "is being launched subject to other local approvals in more than 35 countries outside the US," so there's finally some official information to share with you all. According to the press release:

"Significant design improvements make Enlite sensor more comfortable and easier to use than the previous sensor.  In a clinical study... 85% of patients agreed that sensor insertion was pain free and 86% agreed that the Enlite insertion device was easy to use. The Enlite Sensor is a significantly smaller sensor compared to Medtronic's previous product — 69% smaller in sensor size by volume, 38% shorter in length. Adding to patient convenience, the Enlite Sensor can be worn on the abdomen and buttocks and used for up to six days..."

"When the Enlite sensor is used with the predictive alerts feature on Medtronic systems, diabetes patients have access to hypo detection rates up to 98%. This helps give early warning to people with diabetes so they can take action to prevent dangerous hypoglycemia, which is one of the major concerns of people living with diabetes."

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A first look (thank you to Medtronic for these exclusive photos):

 

 

Enlite is labeled for use with all of Medtronic's 522 (small reservoir) and 722 (larger reservoir) systems, the Guardian REAL-Time Continuous Glucose Monitoring System, their Paradigm REAL-Time System (pump and CGM combo), MiniMed Paradigm Veo System (the enhanced version with low-glucose suspend, currently available in Europe only), and the iPro2 (their clinical CGM system).

So why do we in the US still have to wait for these "landmark" new sensors while they're out in European markets?

We don't know exactly. They won't tell us. They can't, according to FDA regulations.  Although we were honored to be part of a select group of D-bloggers invited to Medtronic's recent Diabetes Advocates Forum, that doesn't mean we were given the blueprints to their every move. Much of Medtronic remains dark and mysterious.

We spoke with Karrie Hawbaker, Medtronic's PR Manager, who explained that FDA rules forbid companies like Medtronic from doing anything that could be construed as "marketing" for not-yet-approved products. As PR Manager, that means her lips must remain sealed. But companies are able to do some previewing of products under development in "scientific" settings (or in focus groups, where participants are required to sign non-disclosure agreements).

Even though Karrie was unable to comment on this, we have deduced what we believe to be the holdup here: the FDA won't approve new sensors to be used with current systems set up for only three-day wear because this would require the patient to circumvent the system's existing instructions and restart the sensor. In Europe, the Veo is already set up to work with a 6-day sensor, and users of other Medtronic systems will simply receive new instruction kits on how to safely restart.

But in the US, a medical manufacturer isn't allowed to market something that requires the patient to ignore the instructions of a previously FDA-approved device. Them's the rules. We're pretty sure Medtronic is feverishly after a work-around. They want the product on the US market as much as we do. Stands to reason, no?

"We really cannot speculate on FDA timelines... Getting a new product approved is an ongoing dialogue between the FDA and the manufacturer," Karrie says.

But just because Medtronic's PR team isn't talking doesn't mean they're entirely mum. Last August, Gary Ellis, Senior Vice President and Chief Financial Officer of Medtronic, stated on a financial call for the first quarter of fiscal year 2011 (ending July 30, 2010): "Looking ahead, we plan on launching our NexSensor in the US later in FY11, and the Enlite sensor early in FY12."

Medtronic's fiscal year begins May 1st, so "late in FY11" indicates sometime this spring, and "early in FY12" would be sometime later this fall.

And btw: what the heck is the NexSensor? Karrie couldn't tell us, naturally, and all we could find was a reference to a study of 6-day use, same as the Enlite. Why would the company launch two new sensors one right after another? Without any insight here, it sounds like a colossal waste of resources...? Another TBD.

 

Meanwhile, something else juicy from the rumor mill, which we've been able to validate this week with some details:

Animas' new pump-CGM combo system in development, called the Animas Vibe, has been filed for CE Mark approval in Europe with a planned launch there in 2011, according to that company's PR Manager Caroline Pavis.

As you may have heard, Animas is partnering with DexCom to develop this CGM-enabled pump system, which combines DexCom's continuous glucose monitoring system with an Animas insulin pump "to provide greater insight into glucose level trends." Animas recently offered an exclusive "first look" at the Animas Vibe at the ATTD and Diabetes UK meetings in London, where the product was displayed under glass — as is typical for pre-approved systems.

We're told that the Vibe will use Dexcom's fourth-generation sensor, which will be smaller and more accurate than the SEVEN PLUS (!), and be based on the same platform technology as the Animas 2020 pump (although slightly elongated to accommodate the CGM), including features like:

  • Waterproof pump casing, in choice of colors
  • High-contrast color screen
  • Small basal rate increment (0.025 U/hr)
  • Personalized audio alerts - Compose your own tune or set to vibrate (I wish the OmniPod had that!)

That's all we know about that for now. Except of course that Europe will get the Vibe first.

Invented here; Enjoyed there.  Grrrr.

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UPDATE 4/28/2011

We just got our hands on a first-look photo of the Animas Vibe. Check it out:

 

 
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