A meeting of the Circulatory System Devices Panel was held on December 4 and 5, 2000.
On December 4, the panel considered a reclassification petition to downclassify percutaneous transluminal coronary angioplasty (PTCA) catheters from Class III to Class II. The sponsor heard a presentation by Cook, the sponsor of the petition, and from FDA. In addition, the panel considered two letters submitted by members of industry in support of the downclassification petition, and one comment by industry against the petition. The Panel recommendation was for downclassification of these devices. Seven panel members voted ‘yes’, that there was sufficient information to establish special controls to provide a reasonable assurance of safety and effectiveness (under Class II). One panel member voted ‘no’, that there was insufficient information, and the devices should remain in Class III.
On December 5, the panel discussed, made recommendations, and voted on a premarket approval supplement application, P980050/S1, for the Medtronic Jewel AF "AF Only". Medtronic sought approval for the implantable cardioverter defibrillator to be used in the treatment of patients with symptomatic, drug-refractory atrial tachyarrhythmias and/or ventricular tachyarrhythmias. The device includes the Patient Assistant, which is a hand-held activator that allows patients to determine the timing of the defibrillating shock.
The Panel heard a presentation by Medtronic on the results of the primary clinical study used to support the safety and effectiveness of the Jewel AF. The study was a prospective, multicenter, non-randomized clinical study in which 144 patients were implanted with the Jewel AF. The primary effectiveness endpoint was the degree of success in terminating spontaneous atrial tachyarrhythmias, including atrial fibrillation. The primary safety endpoint was a calculation of the relative risk of adverse events.
Following these deliberations, the Panel unanimously (7-0) voted to approve the device with several conditions. The conditions included the need for a post-market study, a re-analysis of the existing data, and the need for patient education and training in the use of the Patient Assistant. They also gave specific recommendations for modifications to the labeling, including specifying "atrial fibrillation" in the Indications for Use, rather than "atrial tachyarrhythmias".
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