Pacemaker, Ablation Atrial Fibrillation Studies Evaluated By FDA Panel
This article was originally published in The Gray Sheet
Executive Summary
Quality of life endpoints are sufficient for approving implantable pacemakers and defibrillators as treatments for atrial fibrillation, even without assurances that the devices provide long-term clinical benefit, FDA's Circulatory Systems Device Panel concluded April 6 in Gaithersburg, Maryland.
You may also be interested in...
ADOPT-A Trial Kicks SJM Into Overdrive In Race For AF Suppression Pacing
St. Jude said it expects to earn the first PMA approval of a pacing algorithm for the treatment of atrial fibrillation (AF) based on its Atrial Dynamic Overdrive Pacing Trial-A (ADOPT-A).
ADOPT-A Trial Kicks SJM Into Overdrive In Race For AF Suppression Pacing
St. Jude said it expects to earn the first PMA approval of a pacing algorithm for the treatment of atrial fibrillation (AF) based on its Atrial Dynamic Overdrive Pacing Trial-A (ADOPT-A).
Non-Randomized Trials Okay For Atrial Fibrillation RF Ablation Trials - Panel
Radiofrequency ablation catheters could be evaluated for treatment of atrial fibrillation (AFib) through non-randomized studies using patients as their own control, members of FDA's Circulatory System Devices Panel concluded at their July 21-22 meeting.