Johnson & Johnson unit gets FDA approval for catheter component of Sterotaxis system

By Ted A. Knutson

Washington, Dec. 19 - Johnson & Johnson Inc.'s Biosense Webster, Inc. received approval from the Food and Drug Administration Friday for the Celsius RMT Diagnostic/Ablation Deflectable Tip Catheter designed to integrate with the Niobe Magnetic Navigation System from Stereotaxis, Inc.

The approval of the Celsius RMT 4 mm ablation catheter by the FDA provides electrophysiologists in the United States enhanced maneuvering capabilities when using the Niobe Magnetic Navigation System to perform cardiac ablation procedures, Stereotaxis said Monday.

The FDA approval received for the Celsius RMT ablation catheter represents the first ablation catheter to be commercialized in the United States under Stereotaxis' strategic alliance with Biosense Webster. The Celsius RMT ablation catheter received CE Marking Authorization for commercialization in Europe in March.

Stereotaxis is a St. Louis biotechnology company.

The announcement was made in a Stereotaxis 8-K filing with the Securities and Exchange Commission.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.