Clinical Investigation Plan (CIP) Endpoint Definition: The proportion of participants with freedom from CEC adjudicated device- or procedure-related SAEs.

The CEC established criteria to determine the relatability of an adverse event (AE) to the device and/or the index procedure. Based on these criteria, AEs were adjudicated to be "definitely related", "possibly related", or "not related". Events adjudicated to be "definitely" or "possibly" related were considered to be related events.

NOTE: Due to early termination of the investigation, this endpoint is presented as the number of participants with freedom from CEC adjudicated device- or procedure-related SAEs.

CIP Endpoint Definition: The number of interventions per patient years to facilitate and / or maintain AVF use (facilitation interventions and / or maintenance interventions). The assessment of interventions to facilitate and/or maintain AVF use started post creation (after the completion of the index procedure).

NOTE: For the calculation of the endpoint, the number of Interventions per Patient Years to Facilitate and / or Maintain AVF Use was to be estimated by using the Poisson regression model. Given the early termination of the investigation the mean and standard deviation of the Number of Interventions and Patient Years used for the derivation are provided in the Analysis Population Description.

To provide details on the calculation on the rate given the early termination of the investigation - the mean (standard deviation) number of interventions used was 0.5 (0.76) and the mean (standard deviation) number of patient years used was 0.5 (0.20). This provided the rate presented in the Outcome Measure Data Table.

CIP Endpoint Definition: The proportion of participants with freedom from CEC adjudicated device- or procedure-related SAEs.

The CEC established criteria to determine the relatability of an adverse event (AE) to the device and/or the index procedure. Based on these criteria, AEs were adjudicated to be "definitely related", "possibly related", or "not related". Events adjudicated to be "definitely" or "possibly" related were considered to be related events.

NOTE: Due to early termination of the investigation, this endpoint is presented as the number of participants with freedom from CEC adjudicated device- or procedure-related SAEs. This included the assessment of the 12 participants that reached 6-months prior to investigation early termination. No further related SAEs were identified in this time period from the one part of the primary safety endpoint.

CIP Endpoint Definition: The proportion of participants with AVFs that meet the CIP definition of physiological maturation as measured by DUS. Core Lab data was the primary source for endpoint derivation. In the event where core lab data was unavailable, site reported data was used.

Physiological maturation was defined as an AVF having at least 500 mL/min of flow in the brachial artery and an outflow vein diameter of ≥4 mm as measured by DUS. Participants with AVFs that met the definition of functional maturation were automatically considered to have met the endpoint of physiological maturation.

NOTE: Due to the early termination of the investigation this endpoint is presented as the number of participants with AVFs that meet the definition of physiological maturation as measured by DUS.

CIP Endpoint Definition: The interval of time between HD arteriovenous (AV) access creation to first successful use for HD and proportion of participants with successful first use for HD as defined in the CIP. Cannulation Success is defined as the first successful use for HD using 2-needle cannulation.

NOTE: Given the early termination of the investigation, this endpoint is presented as the percentage of participants with successful first use for HD. The Kaplan-Meier (KM) method was used to estimate the proportion of participants with success at 6 months.

NOTE: The overall assessment of the fourteen (14) participants includes three (3) incident (pre-HD) participants that never required HD during the investigation. The % of the eleven (11) subjects that were eligible for HD during the course of the investigation that achieved cannulation success prior to investigation early termination is also provided in the outcome table.

CIP Endpoint Definition: The interval of time between HD arteriovenous (AV) access creation to first successful use for HD and proportion of participants with successful first use for HD as defined in the CIP. Cannulation Success is defined as the first successful use for HD using 2-needle cannulation. The median time to success was to be estimated using the Kaplan Meier curve and defined as the time at which 50% of participants reached success by the end of the 6-month window. By the end of the 6-month window, the estimated success rate was 46.2% (see Secondary Outcome above "Cannulation Success - Percentage of Participants With Cannulation Success") as such, there weren't sufficient data points with successes to get this estimate. Instead the minimum and maximum number of days to cannulation success for all participants through investigation early termination is provided.

NOTE: The overall assessment of the fourteen (14) participants includes three (3) incident (pre-HD) participants that never required HD during the investigation.

CIP Endpoint Definition: The time from first successful HD AV access use for HD using 2-needle cannulation to access abandonment, when the access reaches an access censoring event as specified a priori in the CIP, or analysis timepoint / clinical investigation end.

NOTE: Given the early termination of the investigation the endpoint is presented as the number of participants that had met the definition of cumulative functional patency - those that (1) had initiated HD successfully through their AVF with 2-needle cannulation and (2) whose AVF was not abandoned.

For the five (5) participants that had sufficient follow-up time prior to investigation termination, the cumulative functional patency through 6-months was evaluated.