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|Stereotaxis Initiates Multi-Center Randomized Superiority Study on Ventricular Tachycardia Ablation Outcomes|
“The Niobe system is uniquely well-suited for the treatment of arrhythmias in difficult-to-reach, complex anatomy, such as VT, and has an outstanding performance record in safety, acute success and long-term results with VT ablation,” said
Researchers from U.S. and European sites will conduct a prospective, post-market, randomized controlled trial involving 382 patients and designed to establish the superiority of VT ablation outcomes using the Niobe ES system versus a manual approach in a low ventricular ejection fraction population. The study, named the “MAGNETIC VT” study, will be led by Global Principal Investigator Dr.
Dr. Natale and a group of U.S. physicians recently conducted a multi-center, retrospective study comparing long-term success rates with the Niobe system and manual approaches in VT. The findings of that study revealed a substantially greater long-term success rate among the Niobe patient group (81.2% vs. 69%) and were published at the American Heart Association Scientific Sessions.
“Finding the optimal treatment for VT is a very important clinical topic, and the MAGNETIC VT study is one of the few randomized clinical trials being conducted around the world that can lead to meaningful insights on the topic. Through this upcoming study, we have the opportunity to determine if treatment of VT with the Niobe system is superior to manual approaches, which would further support its classification as the standard of care,” said Dr. Natale.
Patient enrollment is expected to begin shortly, with follow-up occurring at three, six, nine and twelve months. The primary endpoint is freedom from any recurrence of VT through one year. Participating centers, each considered VT centers of excellence, include:
The core components of Stereotaxis’ systems have received regulatory clearance in
This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe”, "estimate”, "project”, "expect" or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company's ability to raise additional capital on a timely basis and on terms that are acceptable, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness on acceptable terms, continued acceptance of the Company's products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in
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