AGA Medical gets IDE approval to judge AMPLATZER Cardiac Plug AGA Medical Holdings.

These patients shall be followed for 45 days after the procedure and evaluated for adverse events. The 45-day time feasibility data will become reviewed by an independent data safety monitoring board ahead of FDA review. Additional topics will be enrolled in the pivotal phase of the trial following the FDA has finished its review. Scientific data possess demonstrated that sufferers with a center arrhythmia, called atrial fibrillation, face a five-fold higher incidence of stroke. Clinical research has further demonstrated a stroke in these patients is linked to a small structure, shaped like a pouch, off the left atrium of the center called the LAA.Subjects ranged in age from 35 to 73 years, with a mean age of 50 years. Fourteen of those referred for surgery suffered from pain caused by disk disease, three had disc instability at levels next to discs that had previously been fused, and four suffered from progressive degenerative scoliosis. Seventeen of the 21 patients underwent medical procedures for a single-level fusion . One individual had a two-level fusion, and three sufferers underwent medical procedures on three amounts.