If you are an Animas insulin pumper and would like to try out Johnson & Johnson’s latest version called the “Vibe™,” you may have to do some traveling to visit Big Ben later this summer. On Friday, Animas(R) Vibe™, the first integrated offering from Animas Corporation And Dexcom, Inc., received European CE Mark Approval, which essentially means J&J will be able to sell this new and improved insulin pump to patients via European private care or state run health services. Initially, the Animas pump will be available in the UK, Germany, Sweden, France and Italy (all European countries with large numbers of type 1 patients). A United Kingdom Animas representative stated that the first stock of “Vibes” will arrive at the end of June 2011. The Vibe™ looks slick, although it is a second entry to the market after Medtronic was first to the market with the Paradigm, and then again, after the second-gen Medtronic integrated pump, called Veo was launched everywhere but the USA early this year (the FDA has not approved the Veo’s “low glucose suspend” system – see more on that feature here.) Device manufacturers are competing to see who has the best features or add-ons. Now that Animas has an integrated CGM system with Dexcom, they are on a level playing field with Medtronic, but who likes to be second to market? No successful marketer, that’s certain.
There’s a bigger question here. Why did Animas launch its fully integrated pump in Europe first? Perhaps because Europe actually has the second largest population of type 1 patients (0-14 years old) in the world - SE Asia (Number 1 in the world for highest percentage of type 1 patients) and Europe each have a larger number of children with diabetes than the entire North American continent (USA and Canada). Even more enticing for the device companies is how many European health systems stipulate that insulin pumps are medically necessary for type 1 children and as such, pumps are distributed (including monthly supplies) to those children (or parents) who want them.
The fact that the fastest growing type 1 patient populations are in Europe and SE Asia is really the big news story here. There is no doubt that the US and Canadian markets are important, but a shift has been and is occurring today. Medtronic’s Veo was also launched in Europe and Asia before the USA and while Medtronic has filed for approval in the USA – it still hasn’t been approved for North America. Is the FDA exerting a tough power play or is there a backlog of device approvals? I suspect it may be the latter as the European Union tends to be very tough on drug and device approvals (as well as costs), but is far more pro-active than the FDA at fast-tracking products that really benefit a specific patient population. What exactly is the FDA doing? …a few d-bloggers ask. I wonder if it isn’t the device makers who are holding off on their 510(k) submissions to the FDA in order to make immediate profits and gather significant clinical data … thereby enhancing scientific review. Of course, I could be wrong, but one fact remains–the USA is quickly becoming the last market where companies launch newly enhanced insulin pumps.