The last thing any company needs especially one that is trying to establish itself in the crowded and growing CGM market is a recall. Unfortunately that’s exactly what happened with Senseonics. Per a story posted on the Mobihealthnews site;
“The FDA has issued a class two device recall for Senseonics’ Eversense continuous glucose monitoring system. This posting follows a September notice from the company that alerted providers and distributors in the US that the sensors of certain devices may stop working prematurely.”
This from the company’s web site:
“Senseonics identified a small number of Eversense Sensors that have prematurely stopped functioning due to inadequate hydration of the sensor’s glucose-sensing membrane. Our investigation found the presence of residual sodium chloride solution used during the manufacturing process from one specific manufacturer. In such cases, the Eversense CGM System stopped displaying glucose information to the user and ended sensor life earlier than expected (within first 3 weeks following insertion). As of September 4, 2019, twenty-four (24) sensors covered by this action prematurely stopped functioning, which is 1.4% of the sensors inserted over the affected period. If an Eversense user’s sensor stops early, he/she will need to undergo sensor removal and insertion procedures. The common risks associated with the procedure include pain and discomfort, redness or erythema and small risk of infection at the sensor site (post-market analysis is 0.42% infection rate).
Senseonics has implemented changes in the manufacturing process to address this issue and ensure appropriate removal of sodium chloride.”
A few points here as recalls are unfortunately a common occurrence with medical devices. Senseonics will not be the first nor the last toy company to issue a recall. However for Senseonics this recall is particularly damaging as it does point to major issue with their Eversense platform, namely when something goes wrong and with medical devices something always goes wrong, the patient doesn’t simply take it off and slap on a new device. Since the Eversense system is implanted when something goes wrong it has to be REMOVED from the body.
Now this removal procedure may be simple and relatively painless but that really doesn’t matter as it still has to be removed and this removal cannot be done by the patient. The patient has to go see their physician who will remove the defective sensor and then if the patient still wants to use the Eversense replace it with a new one. This is a major pain not to mention the time consumed and cost involved.
Senseonics was already facing a number of issues and this recall could not come at a worst time. Yes, the company did the right thing and should be commended for being proactive. However no matter how you slice this it does not reflect well on the company and will only draw an even starker comparison between the Eversense platform and its competitors the Dexcom G6 and FreeStyle Libre. As everyone we had nothing against the Eversense system we just don’t like the business model as we see no path to profitability. This recall has just put one more obstacle in that path.
Speaking of the competition Dexcom received some excellent news as Walgreens announced they are making it easier for Medicare patients to access the system. According to a company issued press release;
“Walgreens is launching a new billing solution to allow Medicare patients who use the Dexcom G6 Continuous Glucose Monitoring (CGM) System to fill their prescription at any of its more than 9,200 U.S. retail pharmacy locations. Walgreens is now the largest retail pharmacy chain providing nationwide distribution for Dexcom CGM.
Currently, prescriptions for CGM devices covered by Medicare Part B are filled through Durable Medical Equipment suppliers, manufacturers or limited pharmacies, which can result in additional healthcare costs and delays in obtaining devices. With Walgreens new billing solution, patients who are prescribed the Dexcom G6 will be able to obtain the system quickly and conveniently at their local Walgreens pharmacy.”
Not to overstate the obvious here but this news is just further reinforcement of our view that when it comes to CGM this world belongs to Dexcom and Abbott. And yes, it is that simple.
One company that continues to struggle with their CGM platform is Medtronic. While Dexcom and Abbott continue to gobble up patients Medtronic cannot get out of their own way. Besides being inferior technology the company’s main supplier IntriCon notes that sales are slowing. The simple fact is sales of the 670G continue to disappoint and will only slow further when the Control IQ from Tandem gets here.
The harsh reality for Medtronic Diabetes is this, until they can fix the issues with their CGM sensor nothing else really counts. As sensor augmented systems continue to become the platform of choice for insulin pump patient’s sensor accuracy and reliability are trumping the pump itself which quite frankly has become a commodity. This is why there is such a high level of enthusiasm for the Control IQ besides having a more patient friendly user interface combined with connectivity, the Control IQ also works with the Dexcom G6 sensor which is widely acknowledged as the most accurate and reliable sensor available.
We’ll say it again as it’s wroth repeating CGM belongs to Dexcom and Abbott with everyone else being mere spectators.