An all-in-one, fully-disposable, three-day infusion set with hidden needle and four-step insertion was just made available in the US; early feedback OUS has been “fantastic” with 85% of users preferring Mio Advance over previous infusion sets
Medtronic just announced US launch of its 3-day wear MiniMed Mio Advance infusion set that was approved last year. The set is inserted in a simple “peel, pinch, place, and press” four-step insert process and enables a variety of new features: (i) one-handed insertion and flexibility to access insertion sites on the lower back or back of the arm – being able to do “one-handed” is very convenient, especially for those that live alone or like to be more independent; (i) fully hidden needle before, during, and after insertion; (iii) consistent insertion force with a built-in insertion device called a “serter” – historically, this has been associated with less pain though strides made on pain have already been huge; (iv) fewer insertion steps – anything that translates to lower real and perceived “hassle factor” is a positive; and (v) improved rotation of infusion set sites to enhance insulin absorption and prevent lipohypertrophy – this last is a very big deal and under-reported as we understand it.
We got to see the MiniMed Mio Advance back at ATTD 2018 and were impressed by its user-friendliness. The infusion set, developed and manufactured by Unomedical and distributed by Medtronic, is also limited to use with a 6 mm cannula and features 90-degree insertion. The product is the latest of four types of infusion sets Medtronic has available online including the MiniMed Quick-set (most popular), MiniMed Silhouette, and MiniMed Sure-T. Medtronic’s website has a handy document that provide step-by-step instructions and videos on how to insert each device.
The MiniMed Mio Advance was first launched in 2018 among several countries OUS in Europe, including the UK, Italy, and the Netherlands. Notably, data from these countries show that 85% of those OUS users prefer Mio Advance to their previous infusion sets and that early feedback on the product has been “fantastic.” The press announcement features two reviews from Medtronic Ambassadors, one father of a 13-year old Medtronic pump user who championed the ease of removal and another citing the benefit of not having to carry a separate inserter, which we believe reflects lower hassle factor. Of relevance to US customers, Medtronic’s website states that a box of 10 Mio Advance infusion sets is available for $194.23 ($19.42 each, must have a prescription) and that costs are covered by “most” insurance companies.
Medtronic and Unomedical are also continuing to work on a 7-day infusion set (“Extended Wear Infusion Set”). Announced at ATTD 2020, Medtronic’s 7-day extended wear infusion set utilizes the new Mio Advance automatic inserter and received CE-marking this spring, following a small study (n=21) showing 81% survival rate at 7 days. Per ATTD, launch of the extended-wear infusion set in “select countries” is planned for “early 2021.” At ADA 2020, Medtronic presented data showing that three new adhesive patches had 7/8 day survival rates of 95%, 75%, and 100%. Medtronic is also in the midst of a pivotal trial for the 7-day infusion set after receiving IDE approval back in August 2019. The multi-center, non-randomized, prospective, single-arm pivotal study (n=150) compares current 2-3-day infusion sets to the new 7-day extended wear sets.
Currently, there are no 7-day infusion sets approved in the US, and there is minimal competition for Medtronic on that front.
Last we heard at ATTD 2019, Capillary Biomedical was aiming for a 2020 launch of its 7-day SteadiFlow infusion set, although we have not heard updates since then and anticipate that the COVID-19 pandemic likely pushed back any timeline for achieving that goal.
Although there is minimal competition for infusion sets lasting beyond three days, we think it’s terrific that Medtronic is moving ahead so well on this front – it makes a lot of sense since the economics of pumping can be improved meaningfully. Although historically, insulin sets may have “seemed” like commodity items, they are anything but. The manufacturing for the sets is complex, with high precision of absolute importance – presumably, the sets would be priced the same and cost less over time to manufacture, which would mean that more value could be passed on to patients and payers through lower prices for pumping overall, or that possibly, sets would be priced slightly higher, meaning higher profitability for Medtronic on a per-set basis. It will be interesting to see how Medtronic makes these pricing decisions since all else equal, a longer-lasting set priced the same as traditional sets will by definition mean lower profitability per pump patient. We do certainly know many infusion sets are used well beyond three days, particularly for patients who use lower amounts of insulin, for exactly this reason – patients have to re-order less frequently, and they save funds. We’ll be watching where this goes … kudos to Medtronic for creating a better process for sets and for patients and for payers.
--by Katie Mahoney, Ani Gururaj, Albert Cai, and Kelly Close