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


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

This article was originally published in The Gray Sheet

Executive Summary

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.

You may also be interested in...

New Products In Brief

AtriCure’s Synergy surgical ablation system for atrial fibrillation and J&J/DePuy’s next-generation polyethylene bearing for rotating platform and mobile bearing knees gain PMA approvals. More new products.

AF Ablation: Surgery And Catheter Techniques Both Shine At AHA

Atrial fibrillation treatments involving standalone surgical ablation and catheter ablation were discussed in data presentations at the American Heart Association annual meeting last week.

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.

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