Stereotaxis Announces Expanded European Labeling for Navigation in the Pericardial Space

Stereotaxis Inc., a global developer of robotic technologies for the treatment of cardiac arrhythmias, announced that navigation in the pericardial space has been added to the CE Mark of the Niobe magnetic navigation system in Europe.
 
“We pursued this indication to further enhance our ability to help treat the most challenging arrhythmias,” said David Fischel, chairman and CEO. “The architectural superiority of Stereotaxis technology is particularly valuable in this type of procedure. Stereotaxis remains committed to enabling the safe and effective treatment of a broad range of arrhythmias including those that are difficult or impossible to treat with conventional approaches.”
 
The pericardium is a fluid filled sac surrounding the heart. While cardiac ablation is typically performed on the endocardial surface from within the heart chambers, the cardiac tissue in the ventricles is sometimes too thick to allow for the creation of transmural lesions from the endocardial surface alone. There is growing recognition that epicardial ablation, ablation of the heart muscle from outside the heart in the pericardium, is valuable for more effective treatment of a broad range of complex arrhythmias. Navigation in the pericardial cavity entails unique challenges and conventional catheter technologies may not provide the reach and precision required to consistently be able to treat these arrhythmias.
 
“The Niobe system performs flawlessly during pericardial navigation,” said Dr. Bruno Schwagten, M.D., Ph.D., Middelheim Hospital, Antwerp, Belgium. “By directly manipulating the catheter tip, the Niobe system enables easy access to the whole pericardial area and allows the operator to visualize and target epicardial substrate in an unprecedented fashion.”
 
“I appreciate the flexibility that using robotic magnetic navigation provides,” said Professor Petr Neužil, M.D., Ph.D., FESC, head of Department of Cardiology, Homolka Hospital, Prague, Czech Republic. “I don’t need to be concerned with having a specific sheath or needing to choose whether to gain anterior or posterior access. I can use creative approaches to access hard-to-reach areas.  Safety is also of great importance and catheter navigation with the Niobe system reduces the risk of adverse events versus other technologies.”
 
Stereotaxis develops robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Over 100 issued patents support the Stereotaxis platform. The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Japan, Canada, China, and elsewhere.