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7 Responses

  1. David
    David May 21, 2010 at 8:06 am | | Reply

    Clever! Thank you for the update. I hope the “very low cost to manufacture” translates to a significantly cheaper product that would allow the 75% of us who don’t pump to have this choice.

  2. Wendy
    Wendy May 21, 2010 at 9:24 am | | Reply

    I’d love to know when (if) the Solo is ever going to debut…and…the Aviator too, while we’re at it.

    Addy wears the Ping and I actually don’t need to access the pump much, if ever, during a site rotation. I pulled it out the other day when she left her Ping remote at school, and needed a bolus….aside from adjusting dosages, it just stays in her pump pack with the tubing tucked inside. Dislodged sites just don’t happen around here. The site looks cool, but we don’t have any issues with sites getting pulled out, so I’m not sure I’d rock the boat to switch from something that’s already working.

  3. Kassie
    Kassie May 21, 2010 at 1:02 pm | | Reply

    dislodged sites are a huge issue for us. The full-on-yanked-out situation is usually noticeable but we have a lot of leaky sets after soccer practice/games. I’d love to try this set!

  4. pumpmavin
    pumpmavin May 22, 2010 at 8:37 am | | Reply

    Having seen the infusion set, it lookls like the ‘pulled out site detector ‘ will only detect some, but not all , of the ways sites can fail.

    The detector is really a spring loaded lever that lays against your skin under the tape. If the site falls off, your skin is no longer holding the lever and the sporing pulls it into a position that plugs the infusion set. From there, the pressure will build and the occlusion alarm will eventually kick in, warning you that you have a problem. So, It works if the site falls off completely but is may not work for the more likely, “site pulled out but the tape on this part is still holding it in place” sort of problem.

    I worry about any spring loaded pump drive, like this one. Unlike an electronically driven pump (every other pump on the market today for diabetes), all the energy needed to deliver the insulin is being applied to the back of the reservoir from the spring at all times. The insulin is held back by a valve that opens to allow delivery in small amounts. The trouble comes if the valve metering the insulin fails open. Getting an entire reservoir of insulin due to this type of failure would not be a good day for anyone.

    Lastly, detecting bubbles is cool, but, if very small bubbles (the kind you can typically ignore) would trigger this alarm, It would become more trouble that it is worth.

  5. Ziki Gold
    Ziki Gold May 23, 2010 at 1:36 am | | Reply

    I had the opportunity to discuses some of the concerned issues with these guys and have realized that device is protected against valve failure by a number of safety circles including a contingency derange of all left insulin into the pump housing, in order to avoid any likelihood for uncontrolled insulin to ever reach the body.
    About the air bubbles, I was assured that this pump would automatically compensate for very small bubbles while generating an alarm only in presence of more significant ones.

  6. bp
    bp May 23, 2010 at 2:02 am | | Reply

    As far as I know, the Adi pump has FDA approval. You can see it on their website.
    However, they have not yet announced the FDA approval of the infusiion set. Are you sure that they have received FDA approval?

  7. Rickst29
    Rickst29 May 26, 2010 at 3:04 pm | | Reply

    bp: I think that the approval the show their isn’t applicable anymore, it was informally “pulled”. Approval on June 6, 2008, was awarded in response to a 510(k) application. The 510(k) process allows a company to “grandfather in” a medical device, if a substantially equivalent device was already on the market in 1976. The NiliMedix Application and FDA acceptance summary are at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070844.pdf

    They claimed equivalance to the Minimed 508. It won 510(k) approval in 1999, referring to older predecessors, which in turn led all the way back before the critical 1976 date. But probably, FDA has later advised (quietly) that NiliMedix must NOT use this approval to go to Market: Because, as Amy has described, the use of a spring-loaded cartridge is not “substantially equivalent”, it’s new technology.

    Their letter DID say that “a custom reservoir is driven by insulin pressure to deliver preset basal profiles and patient-programmed bolus of insulin through FDA cleared infusion sets….” But they provided no details. This happens in motor driven pumps, too: the motor squishes the cartridge, the higher pressure causes the insulin to leak into the body through tubing and infusion set. Dr. Lin seems to have misread this in granting the finding of “substantial equivalence”.

    But, right in the reply, Dr. Lin warns Mr. Levy to note the regulation entitled “Misbranding by reference to premarket notification”, and Mr. Levy might have gulped hard right then. Furthermore, the device was approved within Class II, and *that* put it under other regulations as well.

    Whether or not the device can go to market without a full PMA review isn’t clear — the 510(k) hasn’t been revoked, but I’ll SWAG that we’ll see a PMA application shortly. (Rather than waste lawyers’ time, FDA probably just told NiliMedix to do a full PMA, without revoking the 510(k) approval.)

    Over at ClinicalTrials.gov, http://clinicaltrials.gov/ct2/show/NCT00797771, they’ve got a “User Satisfaction” survey which has been stuck in “currently recruiting participants” stage for about 18 months. This could be more evidence that they’re being forced into the full PMA-based process — such a study, consisting of “independent home use”, can’t be done until AFTER it’s reached PMA status.

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