A catheter using magnets to destroy unhealthy tissue that affect the heart rhythm Celsius RMT ThermoCool catheter, by Steroetaxis has been approved for sale in USA.
US Food and Drug Administration approved Stereotaxis’ Celsius RMT ThermoCool catheter, announced Stereotaxis.
Stereotaxis’ Celsius RMT ThermoCool catheter was approved in Europe in October 2009.
Celsius RMT ThermoCool catheter has received CE Mark for distribution in the European market.
Celsius RMT ThermoCool catheter is the fifth advanced ablation catheter resulting from the on-going co-development agreement between Stereotaxis and Biosense Webster to design and distribute magnetically enabled catheters for use in the Niobe Magnetic Navigation System (MNS).
A pre-market approval (PMA) application supplement for the Celsius(R) RMT ThermoCool(R) catheter was submitted to the U.S. Food and Drug Administration in September.
The Celsius RMT and NaviStar RMT families of catheters are the only magnetic catheters accurately matched to the navigational software of the Niobe(TM) MNS for optimal performance and highly precise catheter manipulation.
Celsius RMT ThermoCool catheter fills out the family of magnetic irrigated catheters to offer both localized and non-localized technology.
Localized catheters are used for more complex arrhythmias requiring 3D electro-anatomic mapping for precise diagnosis, whereas non-localized catheters are typically used for simpler arrhythmias which can be treated using basic imaging and ECG recordings.
Stereotaxis designs, manufactures and markets instrument control system in the treatment of coronary artery disease and arrhythmias.
The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites.
This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure.
The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada.