AGA Medical Wraps Up Septal Occluder Trial Enrollment For ASD Repair
This article was originally published in The Gray Sheet
Executive Summary
AGA Medical plans to submit initial data in early 1999 supporting a premarket approval application for its Amplatzer septal occluder for treatment of atrial septal defects. Over the next two to three months, the company expects to complete the control arm of the pivotal study, a prospective surgical cohort.