In order to be included in the primary objective analysis, insertion procedure-related adverse events must also include resolution by invasive action such as device removal, device replacement, surgical repositioning of the device, or another surgery preformed related to the device or primary insertion procedure.

The evaluable subject population is the sum of total unique subjects who completed the 90-day follow-up and/or who experienced a primary objective adverse event.

All insertion procedure-related adverse events not included in the Primary Objective

The evaluable subject population is the sum of total unique subjects who completed the 90-day follow-up and/or who experienced a secondary objective adverse event.

Position A includes orientations at 45 degrees relative to the sternum over the fourth intercostal space, position B includes orientations parallel to the sternum over the fourth intercostal space, and position C includes orientations perpendicular to the sternum and sub-mammary.

All subjects who underwent insertion

Number of participants analyzed included all subjects with a reported incision size. Incision size was not collected or reported for 3 participants.

This includes average R-wave amplitudes collected at insertion, wound check, and 90-day study visits. Long-term trends available through Home Monitoring from insertion through the 90-day study period was also collected and presented as a separate average.

Five subjects did not complete their 90-day visits as reported in Participant Flow and therefore data was not collected for those visits. Only one subject did not transmit to Home Monitoring due to poor reception and therefore there was no data for this patient in Home Monitoring.