Technical Overview

Magnetic navigation is particularly well suited for the diagnosis and treatment of cardiac arrhythmias. Successful treatment requires precise catheter positioning, often in hard to reach regions of the heart, which can be more consistently achieved using advanced, magnetic navigation. Flexible magnetic catheters contact the wall of the heart in an optimal way, reducing the distortion of the heart wall and improving the quality of electroanatomic maps. By combining the benefits of precise, computer-aided magnetic guidance with optimal catheter contact, Stereotaxis brings the following potential benefits to EP ablation:

• Safer interventional procedures with better outcomes
• Shorter procedures and brief hospital stays;
• Increased likelihood of successful treatment for both simple and complex arrhythmias.

Current medical literature suggests that pacing lead placement has a significant impact on clinical outcomes for cardiac resynchronization therapy (CRT). Stereotaxis' advanced road-mapping tools can provide the physician with the ability to access and evaluate multiple locations in the left side of the heart to optimize CRT function, regardless of the complexity of the coronary vascular anatomy. By bringing precise direct control of the working end of the guidewire and comprehensive integration of imaging information, Stereotaxis brings the potential of added value to CRT:

• Increased likelihood that eligible patients can be successfully treated interventionally;
• Reduction in lead placement time and contrast usage; and
• Lead placement optimization resulting in better long term response rates.

Stereotaxis' advanced road-mapping tools can provide the physician with the ability to access and evaluate multiple locations in the left side of the heart to optimize CRT function, regardless of the complexity of the coronary vascular anatomy. A published comparison study from the Central Baptist Hospital in Lexington, Kentucky has shown that the use of magnetic navigation can reduce both the left ventricular lead placement time and well as the amount of ionizing contrast required for implantation of a CRT device.

Percutaneous coronary intervention (PCI) is the most commonly performed interventional cardiology procedure. Though the majority of PCI cases are quite simple, a significant subset of these patients present with challenging anatomy such as bifurcation lesions, distal pathology, significant vessel angulation and tortuosity, and small caliber vasculature. Stereotaxis magnetic navigation can bring substantial potential benefit to this subset of complex interventional cardiology procedures, including:

• Success in cases that have failed previous non-magnetic interventions;
• Ability to cross lesions in tortuous coronary vasculature; and
• Reductions in both fluoroscopy and contrast required for successful lesion crossing.

Magnetic navigation has been shown to be beneficial in the facilitation of percutaneous coronary intervention (PCI), especially in the subset of these patients who present with challenging anatomy such as bifurcation lesions, distal pathology, significant vessel angulation and tortuosity, and small caliber vasculature. A published study from Dr. Mark Patterson in Amsterdam has demonstrated that magnetic navigation can reduce case time, fluoroscopy time, contrast use, and guidewire cost in patients with complex and distal lesions. Other studies from the Erasmus Medical Center have demonstrated that use of magnetic navigation can lead to success in patients who have previously failed conventional interventional methods.

Magnetic navigation is a broad based platform technology, and the potential applications for interventional medicine are limited only by one's imagination. A wide variety of future directions have been contemplated by several researchers:

• A single center investigational device exemption (IDE) study was conducted to determine the feasibility of using magnetic navigation for lung biopsy.
• A published in vitro study has documented improved speed and accuracy of the magnetic navigation for navigating to cerebral aneurysm sites when compared to standard wires.
• Published animal and human studies in the neurosurgery literature have shown the feasibility of using Stereotaxis to navigate to brain biopsy and aneurysm sites.
• Published studies have evaluated the concept of using magnetic navigation to direct capsule-based endoscopy for gastrointestinal diagnostic applications.
• Two published studies in the interventional radiology literature show successful magnetic navigations in liver and uterine models.
• Additional magnetic navigations have been completed in kidney vasculature models.