Recently, we published an article about the implantable pump “A Miracle Technology for Type 1s: Can It Be Saved?” Following the appearance of this article on the Diabetes Health website, over 100 readers commented, most of them expressing a heartfelt desire for access to this technology in the U.S.A. To read the original article click on link below:
A Miracle Technology for Type 1s: Can It Be Saved?
In response to their comments, Medtronic provided the following letter by Dr. Francine Kaufman. We are publishing it here in its entirety:
Almost two years ago, I left my three-decade long position in academic medicine to come to Medtronic to be part of the effort to develop an artificial pancreas, a fundamental goal for all of us in diabetes research. With all of the work currently underway, Medtronic is committed to bringing innovation and advancement to diabetes therapy.
We have made significant progress on our ultimate goal to provide patients with a fully-implanted, fully-automated pump – a true artificial pancreas. Our work in this area represents the reason I came to Medtronic and why our entire group is committed to helping people with diabetes live a better life.
As we work toward that goal, we are also focused on what we can do today and in the near future to improve the overall health and quality of life of people with diabetes. We are making significant advances in our pump and sensor technology, refining the algorithms that direct our devices to do what we design them to do, and updating our offerings to be more adaptable in today’s constantly changing technology environment.
I tell you this because it’s important to understand the breadth and depth of our work when you consider what Medtronic is doing for people with diabetes. We noted with great interest the recent story in Diabetes Health about our implantable insulin pump and the online discussion that followed. We read first-hand the stories of people who have gone to great lengths to avail themselves of our implantable insulin pump.
As you know, the implantable insulin pump is not approved by the FDA in the United States. It has been made available outside the U.S., most notably in France.
The comments that followed the posted story covered a number of areas, mostly advocating for its broader use and questioning why we have not brought it to the market in the U.S. One thing that we would like to point out is that the implantable pump is not a closed loop system. The people in Europe who use this product still need to test their blood sugar multiple times per day, count carbs and calculate and administer bolus dosages using the pump’s external remote.
In addition, included in those comments were a number of insinuations that we are somehow withholding this device from patients. That is completely untrue.
The reasons why the implantable pump is not available in the U.S. are as follows:
· There are many technical, scientific, clinical, regulatory and healthcare system hurdles. We regularly manage through these, but in some instances, and the implantable insulin pump is one, we need to consider not only our device, but the insulin that is provided through that device. Having one component approved is challenging, having two components is doubly so.
· The implantable pump – in its present form – is difficult to adopt. It is a complex device that requires meticulous attention and care. Refilling and readjusting it is a challenge. We’re working to make the pump smaller and easier to adopt.
· A particular type of concentrated insulin must be used in the implantable pump to provide the best opportunity for an efficacious and safe treatment for the patient. That formulation is still being developed and refined, and the original formulation is no longer available.
· Our research and development budget is robust, but has limits. We work on the innovative advances we believe we can bring to the market quickest so that we can have a more significant impact on the care of people with diabetes.
Developing the next generation of implantable pumps will take significant time and resources. We know there are many innovations that we can bring to people sooner to reduce the burden of diabetes management and improve outcomes. As supported by the roadmap developed by the JDRF, it is within our grasp to have pumps/sensors/algorithms that determine how to deliver insulin automatically, and that can start making big differences in the lives of people with diabetes now and in the years to come. That is where Medtronic is placing the bulk of its resources and efforts, while at the same time it continues to invest in the implantable pump program.
Of course, we are pleased to hear stories from people who report success with our devices. We remain committed to supporting the patients who currently benefit from the implantable pump. However, no device is right for everyone. That’s why we create a portfolio of devices that will suit the broad spectrum of people with diabetes.
We remain committed to listening and engaging with the diabetes community. You are a passionate, informed and motivated group of people who have brought about great change in how this disease is treated and we have no doubt you will continue your tireless advocacy. Your words and deeds motivate us every day to develop innovative treatments which help improve the lives of diabetics everywhere.
I’ve seen a lot of positive changes in diabetes technology in the 32 years I’ve been practicing medicine. It’s exciting to see how far we’ve come. But, knowing how much talent and resources are currently dedicated to developing an artificial pancreas, it’s even more exciting to think about what technology patients might have in the near future.