MINNEAPOLIS – September 27, 2013 –Medtronic, Inc. (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) approval of the MiniMed® 530G with Enlite®, a breakthrough, first-generation artificial pancreas system with Threshold Suspend automation for people with diabetes. Medtronic’s system is the first in the United States that can automatically stop insulin delivery when sensor glucose values reach a preset level and when the patient doesn't respond to the Threshold Suspend alarm. The MiniMed 530G system incorporates the new Enlite sensor, Medtronic’s most accurate and comfortable continuous glucose sensor with a 31 percent improvement in overall accuracy from the previous generation.i
“We’re excited to bring yet another important ‘first’ to the United States. The MiniMed 530G with Enlite can help people gain better control of their diabetes versus multiple daily injections,” said Katie Szyman, president of the Diabetes business at Medtronic. “We are committed to advancing closed loop algorithms, continuous glucose monitoring and insulin delivery technologies to bring new artificial pancreas systems to market.”
The Enlite sensor delivers better comfort and reliable CGM accuracy. In addition to the 31 percent improvement in overall accuracy, the Enlite sensor detects up to 93 percent of hypoglycemia episodes when predictive and threshold alerts are on.ii The Enlite sensor is also 69 percent smalleriii than the previous Medtronic sensor, to deliver improved comfort in using continuous glucose monitoring. The new Enlite server provides a simpler sensor insertion process with a hidden-introducer needle.
The MiniMed 530G system was approved for use by people with diabetes ages 16 and older. Medtronic will conduct a post-approval study including children ages two and older. The Enlite sensor can be worn for six days.
As a condition of approval, in addition to the post-approval study, Medtronic will engage in direct patient follow up and will make certain manufacturing accommodations. These commitments are consistent with the product approval by the FDA and an accompanying warning letter issued to Medtronic on Sept. 19, 2013. Medtronic has already addressed many of the observations noted in the warning letter and is committed to resolving the remaining observations as quickly as possible and in accordance with the product approval requirements. Medtronic is committed to providing safe and effective products for people with diabetes.
Medtronic will begin ramping up production immediately to prepare for a launch of the MiniMed 530G in the next several weeks. In the meantime, customers can find additional product and important safety information at www.medtronicdiabetes.com.
Artificial Pancreas System with Threshold Suspend Automation
The MiniMed 530G system is the first system approved under the new product classification, “OZO: Artificial Pancreas Device System, Threshold Suspend,” created by the U.S. Food and Drug Administration. Threshold Suspend automation automatically stops the delivery of insulin if glucose levels reach a threshold, which can be set by a healthcare provider between 60-90 mg/dL. Once the threshold is met, the MiniMed 530G system will first alert the wearer with an alarm. If the individual is sleeping, unconscious or otherwise unable to react, the system will suspend all insulin delivery for two hours. Insulin delivery can be resumed at any time.
When Medtronic develops a next generation product for diabetes control, it will be designed to fully replicate the function of the pancreas by automatically monitoring glucose levels and delivering appropriate insulin to people with Type 1 diabetes; this future "fully automated artificial pancreas" will truly require minimal to no interaction by the patient user.
Shouldn't an artificial pancreas also pump glucogon? It's an insulin pump with an integrated CGM that has an automatic shut off.
The Enlite Sensor has been available in Canada since Spring combined with the Veo pump ; the cost of one sensor is approx CAN $ 65,00 http://www.medtronicdiabetes.ca/en/paradigm_veo.html
Being used to the previous sensor ...already forgot the name, ha, ha ( the large needle never bothered me ) I needed to do a bit of new learning how to attach to my body .I have the low suspend set @ 3.6 ( x 18 ) and may decide to up it a bit to avoid fewer warnings esp during the night . A pumper buddy of mine helped me initially with insertion ; she was trained by her Pump Nurse ( a recent pumper ) . I am able to get another 15-16 hours of sensor use , after the initial 6 days by starting a " new sensor " .The insulin pump itself has not changed
I have had my pump for just over a year. I called Medtronic and they are letting me trade mine in for $400. I am just waiting for my DR. to write another letter so I can get the newer CGM as well. I am hoping the new CGM is as good as they say and less painful. The current version kinda hurts.
Since I just purchased a new pump this summer I am in line to get this upgrade for free! I am excited about it but concerned also as when I talked to the Minimed rep last week if I understood correctly the pump will not work without the sensor. That is a scary thought because should my insurance decide not to pay for the sensors I cannot afford them. I am new to the sensor world since July of this year. When they work correctly I love the data it gives me. It has helped me not to have as many swings as I was having. I am hoping that the new sensors will be more accurate. Anyone have the new pump and sensor yet?
I'm surprised too, at their comment that the pump will not work without the sensor. If that's the case, I will likely never upgrade, and switch to Animas pump instead.
However, maybe they meant the Low glucose suspend feature would not work without a MM sensor.
It's very possible that people would get the MM 530G pump + sensors to start with, and then for various reasons decide to stop using the sensors, so that really needs to be clarified.
I do not think either , that the comment by ky Woman " if I understood correctly the pump will not work without the sensor." is correct .
I( am in Canada ) am trialing a Dexcom G4 since last Thursday on one side of tummy and other side of tummy the Enlite ...several times I had to shut the Medtronic sensor off , because it hit the Low glucose suspend ; finger poke proved I was around 5.6 ( x 18 ) ...another time sensor showed 14.1 ( x 18 ) and BG again was in the " normal range .Dexcom seems much more consistent..I will have to do some soul searching what my next step is ...I do like the idea of one unit only ( medtronic ) compared to the stand alone gadget
I just got a call from them today. I got my pump back in March 2013 and my CGM back in September 2013 and according to them, it should be completely covered. I had trouble understanding the CSR on the phone (sounded like a 16 year old high school kid and he was talking really fast).
I just started using the new 530g pump and cgm and I think it is so much better when putting the CGM on you have to press the button where the line is or it will not go in right but other then that it is very easy to use and more accurate so fair.
is any one else on it yet
Can you please clarify from the talk above if the pump may be used without the sensor. I am in the upgrade process to the new system but, I would not want to be forced to wear the cgm at all times. Some cycles I give my body a break from the sensor. I called medtronic and they will not answer this question as they just repeat the system is sold as a 'System". I guess they are under contract to only speak of it as a system.
I too would like to know. I can't imagine that the pump would stop working w/o the sensor though. That would be just product suicide.