News | November 06, 2009

Stereotaxis Receives European Approval of an Additional Magnetic Irrigated Catheter

November 6, 2009 — Stereotaxis received notice this week that its Celsius RMT ThermoCool catheter received CE mark for distribution in the European market.

The product is the fifth advanced ablation catheter resulting from the on-going codevelopment agreement between Stereotaxis and Biosense Webster to design and distribute magnetically enabled catheters for use in the Niobe Magnetic Navigation System (MNS).

A premarket approval (PMA) application supplement for the Celsius RMT ThermoCool 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 MNS for optimal performance and highly precise catheter manipulation.

This 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.

For more information: www.stereotaxis.com

Related Content

Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
Roxwood Medical Announces Agreement With Abbott for U.S. Product Distribution
News | Catheters| August 09, 2017
Roxwood Medical Inc. recently announced it has entered into an exclusive agreement with Abbott for distribution of...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Merge Hemo cath lab hemodynamics monitoring system.

Hemodynamic data shown on screens from the Merge Hemo recording system. It is among the newer generation hemodynamic systems for cath labs that are more user friendly and have technologies to speed workflow.

Feature | Hemodynamic Monitoring Systems| August 03, 2017 | Dave Fornell
The current generation of...
Left Atrial Pressure Monitor from Vectorious Medical Technologies Offers New Hope for Heart Failure Patients

On of the top stories in July was the introduction of a left atrial pressure monitor from Vectorious Medical Technologies to prevent heart failure patient hospitalizations or readmissions. Read the article"Left Atrial Pressure Monitor Offers New Hope for Heart Failure Patients."

Feature | August 01, 2017 | Dave Fornell
Aug.
Ohio State Researchers Prove Human Heart's 'Battery' Has Multiple Backups
News | EP Lab| July 27, 2017
July 27, 2017 — There is good news when it comes to the heart’s sinoatrial node (SAN), the body’s natural...
Medtronic Announces First Enrollments in STOP AF First Clinical Trial
News | Ablation Systems| July 24, 2017
Medtronic plc recently announced first enrollments in the STOP AF First clinical trial. The trial will evaluate the...
Overlay Init