Stereotaxis product platform provides fast, predictable left ventricular (LV) lead placements as compared to conventional CRT procedures to treat patients with heart failure. In addition, preliminary information suggests that there is a higher acute rate of successful LV lead implantation of CRT devices as compared to previous performance evidenced by multi-center trials using conventional technology. Our goal is to optimize the cost, safety, predictability and clinical outcomes for this rapidly expanding therapy that addresses the leading cause of hospitalizations among the elderly.

LV lead placement ease. Navigation is made simple virtually anywhere in the coronary venous system – even through tortuous anatomy. Easy magnetic wire navigation has the potential to reduce the number of patients requiring surgery for epicardial lead placement, or, in the worst case, patients not receiving any other treatment. In a sequential study of 50 manual and 52 magnetic cases, 30% of the manual cases had LV lead placement times exceeding 30 minutes. Only 15% of the magnetic cases required over 30 minutes to complete. In the same study, a statistically significant reduction in variability of LV lead placement times using magnetic navigation was observed, as demonstrated by a reduction in the standard deviation of LV lead placement times. (Courtesy of Dr. Peter Gallagher, of Central Baptist Hospital in Lexington, KY submitted for publication)

Reduce sheath exchanges. A survey of 22 procedures at 9 different centers found that the physician had to interrogate at least 2 coronary sinus/LV pacing sites before they found an acceptable lead location in 38% of cases. In 76% of those cases, 3 or more sites were interrogated before an acceptable site was found. (Stereotaxis data on file) Using technology being developed by Stereotaxis, evaluation of multiple pacing sites could be performed without having to exchange multiple conventional wires and pacing leads, thereby reducing the chance of patient complications from extended procedure times, air embolus, etc.

Improved CRT Implant Success. Stereotaxis technology is designed to easily and successfully navigate guidewires throughout the coronary system. Conventional manual CRT procedures are sometimes terminated without successful LV lead implantation. More accurate navigation may improve the success of some of the currently failed implants, maximizing patients’ access to therapy demonstrated to improve outcomes.

Improve procedural outcomes through optimized lead placement. Magnetic wire navigation enables easy evaluation of multiple sites with the confidence to return to a previous site, if needed. Stereotaxis enables quick investigation of multiple locations to find the best combination of ideal acute hemodynamic response, lowest capture threshold, minimal phrenic stimulation, and maximum lead stability.

Faster LV lead placement. In addition to the study mentioned above (LV lead placement ease), a timing study of 68 procedures at 4 centers measuring time from CS access to successful lead implant, the median time was 5.5 minutes. (Stereotaxis data on file.) Faster lead implant times may reduce exposure to X-ray fluoroscopy and reduce other complications related to anesthesia or extended procedure times in these heart failure patients. More efficient lead placement times may also enable performance of more procedures in otherwise overloaded cath labs.