FDA OK’s GORE device to close heart holes скачать в хорошем качестве

FDA OK’s GORE device to close heart holes

W. L. Gore & Associates (Gore) announced the U.S. Food and Drug Administration’s (FDA’s) premarket approval (PMA) of the GORE® CARDIOFORM ASD Occluder for the percutaneous closure of ostium secundum atrial septal defects (ASDs). The FDA approval was supported by data collected from the pivotal stage of the Gore ASSURED Clinical Study which demonstrated 100 percent closure success at the six month evaluation in patients with a successful implant. The pivotal study evaluated the safety and efficacy of ASD closure using the GORE CARDIOFORM ASD Occluder in 125 patients with evidence of right heart volume overload demonstrating the need for defect closure. The study involved patients between the ages of 2 and 84, across 22 investigation sites, including 15 children’s hospitals. The pivotal study met its safety, closure, and technical success primary endpoints. To view the multimedia release go to: https://www.multivu.com/players/Engli...