Merit AK Micro Plug - Post Market Clinical Follow-up (PMCF) Plan

Primary Investigation
Objective:

To demonstrate the long-term safety of the Dr. Amplatz Micro Plug
12 months post implant

Primary Endpoint

Rate of device-related and procedure-related adverse events through 12 months post implant

Secondary Objective

Confirmation of the performance of the Dr. Amplatz Micro Plug

Secondary Endpoint

Evaluation of successful delivery of the Dr. Amplatz Micro Plug

Design:
A prospective, observational, post market clinical follow up.

Number of Patients:
50 subjects will be enrolled.

PMCF duration:
Subjects will be enrolled over 12 months and will be followed up over a maximum of 12 months