Afib News & Events

FDA Approves First Catheter for Atrial Fibrillation Ablation — 11/20/08

We're talked about how no devices are FDA-approved for atrial fibrillation treatment and how a sea-change was coming. It finally arrived as the US FDA just approved the first device for treatment of atrial fibrillation.

The NAVISTAR® THERMOCOOL® Catheter from Biosense Webster (Johnson & Johnson) was approved with the condition that some patients be followed to look at long-term safety and effectiveness.

This should open the door for approval of other devices for treating atrial fibrillation and will also finally allow for more open discussion about treating afib. That's a good thing.

Read more:

• FDA Panel Backs Wider Use Of J&J Heart Device
• FDA Advisory Panel Unanimously Recommends Approval of NAVISTAR(R) THERMOCOOL(R) Catheter for Atrial Fibrillation