Top Device Companies

Biosense Gets FDA Clearance For Heart Catheter System

Biosense Webster, a medical-device subsidiary of Johnson & Johnson, said the FDA has approved its catheter system for irregular heart beats. Biosense plans to begin shipments of its Navistar RMT Thermocool Catheter device within the next few weeks. The catheter is designed to be used with Sterotaxis’s Niobe Remote Magnetic Navigation system, working together to destroy tissue that disrupts heart rhythms. (Click here for more)

“FDA Approves Heart Catheter Used With Sterotaxis System” – St. Louis Post-Dispatch (2/27/09)

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J&J Gets Clearance To Market 2 Devices For Atrial Fibrillation

Johnson & Johnson gained FDA approval to expand marketing for its NaviStar ThermoCool and EZ Steer ThermoCool Nav catheters to treat atrial fibrillation. The FDA said the devices are the first ablation catheters it has cleared for treating the disorder that afflicts 2.2 million in the United States. The devices, which already had approval for treating other types of abnormal heart rhythms, help relieve reliance on drugs that do not work for all patients with atrial fibrillation. The devices were made by J&J’s BioSense Webster subsidiary. (Click here for more)

“U.S. FDA Clears Two J&J Devices For Atrial Fibrillation” – Reuters (2/6/09)

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FDA Approves J&J’s Navistar ThermoCool For Atrial Fibrillation Ablation

Full article reprinted from “The Gray Sheet” - February 9, 2009

With PMA approval Feb. 6, Johnson & Johnson/Biosense Webster's NaviStar ThermoCool and EZ Steer ThermoCool Navigational became the first cardiac ablation catheters approved by FDA specifically for treatment of atrial fibrillation. Find out more.