Kiri

Dear colleagues,

The Spanish Agency (AEMPS) has authorised for two individual patients (March 2023 and March 2024) under Article 59 of the MDR the use of a specially modified pediatric-sized implantable pulse generator, called the Pediatric IPG, which includes a Medtronic Micra sub-assembly (CE marked device) that connects to an epicardial lead. While this makes the leadless pacemaker into one that uses leads, the resulting IPG is significantly smaller than any commercially available pacemaker previously on the market. We were informed by the clinical site that there are no CE marked alternatives for this paediatrics patients.

We have received lately a new application for another patient and we have asked Medtronic about their planning for CE marking and the development of a clinical investigation.

Medtronic states that their plan is to seek market approval in the US first because it seems that they can use real-world evidence from the US implants to support a case for device safety and effectiveness and allow a path to commercialization without a clinical trial in the US. They expect to have the FDA approval in 2 years. After commercialization in the US, they hope to use the information from use in the US to support applications in Europe and other countries. This is a multi-year plan, due to the very small patient population, and the very poor ROI associated with Pediatric IPG.

In the last request there was this information below on the use of the device so it seems that it was only used in Italy and Spain in Europe:

41 devices have been deployed globally: 36 in the US, 3 in Canada, 1 in Italy, and 2 in Spain.

As it seems they do not plan performing clinical investigation in Europe and they want to use compassionate use for the FDA authorization, we would like to know if anyone, beyond Italy, has received an application for derogation for this product or if you have any information or opinion in this regards.

Thank you very much for your help with this, we really appreciate it.

Kind regards,