Update on Endotine CE Mark

The Endotine CE mark Saga continues…

Unfortunately there is still no news about when we can expect to be able to supply Endotine devices again. The most recent update we received was back in June and the estimate of when the CE mark may be reinstated was at least 6 months. This means that in a best case scenario, we would not expect to be able to supply this year but would be looking to begin supplying Endotine again at the beginning of 2020.

In case we haven’t been able to communicate this with you directly, here is a brief synopsis of what has occured…

MicroAire received notification from BSI in 2018 that the “Aesthetic Indications” for Endotine were no longer acceptable and that BSI were now requiring “Medical Conditions” for the Endotine product line.   MicroAire disagreed with this new regulatory assessment and conditions; but began gathering data for the new indication and a retrospective clinical study required from BSI.  A limited amount of Endotine product had been used in non-aesthetic procedures in the USA. 

 MicroAire has spent the last year prior to June 2019 gathering data from a select number of surgeons/facilities that have used Endotine in a Medical Condition.  Because this data is so limited and the requirements from BSI to have a statistical number of patient data sets, these surgeons had to review years of patient history files.  The retrospective clinical study is complete and in final regulatory review with submission to BSI. 

Unfortunately, we do not have control or understanding of how long it will take BSI to review the submission so we just have to wait and see.

I am sorry we can’t provide any clearer informaiton but please rest assured we will advise everyone as soon as we hear from BSI.