Medtronic Gears Up For FDA Panel With Mixed Results From AF Ablation Trial
This article was originally published in The Gray Sheet
Executive Summary
Medtronic could face more questions than expected at an FDA advisory panel meeting later this month for the firm’s Phased RF Ablation System for atrial fibrillation due to mixed pivotal trial results released last week.
You may also be interested in...
Safety Concerns Sink Medtronic A-Fib Catheter Ablation System At Panel
Risks associated with Medtronic’s Phased RF catheter ablation system for atrial fibrillation outweigh the benefits of the device, FDA’s Circulatory System Devices panel concluded in an 8-2 vote on Oct. 27.
Medtronic Makes Another Big Play In A-Fib, Purchases Ablation Frontiers
Medtronic will add anatomically designed radiofrequency ablation catheters for treatment of atrial fibrillation to its fledgling AF Solutions division through the purchase of privately held Ablation Frontiers
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.