Stereotaxis12.01.15
Stereotaxis Inc. has unveiled the results of an independent multicenter study on the procedural benefits and outcomes of patients undergoing radiofrequency ablation therapy for ventricular tachycardia (VT) using the Niobe remote magnetic navigation system compared to manual catheter approaches. The study findings, which were recently published at the American Heart Association Scientific Sessions, represent the most significant long-term outcomes to date with the Niobe system in VT and were considerably better than those in the manual catheter group.
“This study further supports the strength of the Niobe system in finding and eliminating even the most difficult to treat arrhythmias,” said Andrea Natale, M.D., FACC, FHRS, executive medical director of the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center in Auston. “Most notably, our findings revealed a substantially greater long-term success rate among the Niobe patient group – 81.2 percent compared to 69 percent for the manual catheter group – which we attribute to the system’s exceptional mapping capabilities and catheter tip control, enabling operators to accurately pinpoint, access and thoroughly ablate the affected scar area.”
The retrospective study reported on a total of 218 consecutive patients with ischemic cardiomyopathy and scar size greater than 60 cm2 undergoing VT ablation in multiple centers. Eighty patients were treated with manual ablation and 138 patients underwent ablation with the Niobe system. Substrate mapping and an ablation technique utilizing scar homogenization were performed, with the end point of elimination of all abnormal electrograms within and around the scar area. The density of mapping was higher (p <0.001) and the mean mapping time was lower (p <0.001) in the Niobe group when compared to the manual ablation group. Moreover, while acute success was achieved in 99.5 percent of all patients, at 15±6.8 month follow-up, 81.2 percent of patients in the Niobe group were VT recurrence free compared to 69 percent of the manual catheter patient group (p=0.037).
J. David Burkhardt, M.D., of the TCAI at St. David’s Medical Center, who recently completed his 1,000th case with the Niobe system, added, “With manual ablation, VT procedures are time consuming and the outcomes might be adversely affected by operator fatigue. We continue to rely on the Stereotaxis platform to deliver the outstanding results our patients expect and deserve.”
St. Louis, Mo.-based Stereotaxis develops robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional laboratory. More than 100 issued patents support the Stereotaxis platform, which helps physicians provide patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis' core Epoch Solution includes the Niobe ES remote magnetic navigation system, the Odyssey portfolio of lab optimization, networking and patient information management systems, and the Vdrive robotic navigation system and consumables.
The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Canada, China, Japan, and elsewhere. The V-Sono ICE catheter manipulator, V-Loop variable loop catheter manipulator, and V-CAS catheter advancement system have received clearance in the United States, Canada, and the European Union.
“This study further supports the strength of the Niobe system in finding and eliminating even the most difficult to treat arrhythmias,” said Andrea Natale, M.D., FACC, FHRS, executive medical director of the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center in Auston. “Most notably, our findings revealed a substantially greater long-term success rate among the Niobe patient group – 81.2 percent compared to 69 percent for the manual catheter group – which we attribute to the system’s exceptional mapping capabilities and catheter tip control, enabling operators to accurately pinpoint, access and thoroughly ablate the affected scar area.”
The retrospective study reported on a total of 218 consecutive patients with ischemic cardiomyopathy and scar size greater than 60 cm2 undergoing VT ablation in multiple centers. Eighty patients were treated with manual ablation and 138 patients underwent ablation with the Niobe system. Substrate mapping and an ablation technique utilizing scar homogenization were performed, with the end point of elimination of all abnormal electrograms within and around the scar area. The density of mapping was higher (p <0.001) and the mean mapping time was lower (p <0.001) in the Niobe group when compared to the manual ablation group. Moreover, while acute success was achieved in 99.5 percent of all patients, at 15±6.8 month follow-up, 81.2 percent of patients in the Niobe group were VT recurrence free compared to 69 percent of the manual catheter patient group (p=0.037).
J. David Burkhardt, M.D., of the TCAI at St. David’s Medical Center, who recently completed his 1,000th case with the Niobe system, added, “With manual ablation, VT procedures are time consuming and the outcomes might be adversely affected by operator fatigue. We continue to rely on the Stereotaxis platform to deliver the outstanding results our patients expect and deserve.”
St. Louis, Mo.-based Stereotaxis develops robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional laboratory. More than 100 issued patents support the Stereotaxis platform, which helps physicians provide patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis' core Epoch Solution includes the Niobe ES remote magnetic navigation system, the Odyssey portfolio of lab optimization, networking and patient information management systems, and the Vdrive robotic navigation system and consumables.
The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Canada, China, Japan, and elsewhere. The V-Sono ICE catheter manipulator, V-Loop variable loop catheter manipulator, and V-CAS catheter advancement system have received clearance in the United States, Canada, and the European Union.