Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Safety Concerns Sink Medtronic A-Fib Catheter Ablation System At Panel

This article was originally published in The Gray Sheet

Executive Summary

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.

You may also be interested in...

Medtronic Launches Registry Of Phased RF Ablation For AFib

The European registry is the first observational “real world” study of Medtronic’s PVAC Gold multi-electrode ablation catheter.

Device Companies Follow New Map To Atrial Fibrillation

Device therapies for atrial fibrillation (AF) have so far failed to result in compelling efficacy across all types of disease and patients. The rates of elimination of AF following a catheter ablation procedure range from 30% to 80% according to the type of patient and the definition of success. The question of why success rates aren’t yet sufficient after a great deal of investment is an area of active pursuit, and one that opens up the door for next-generation AF device companies seeking to improve upon the results achieved to date.

FDA Panel Narrowly Endorses AtriCure’s Synergy For A-Fib Ablation

FDA’s Circulatory System Devices panel narrowly endorsed an expanded indication last week for AtriCure’s Synergy ablation system to treat certain types of atrial fibrillation during open-heart surgery, despite concerns over safety issues and limited data.

Related Content





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts