Stereotaxis Announces First-Ever, Prospective, Comparative Clinical Trial Outcome for VT Patients
ST. LOUIS, Sept. 8 /PRNewswire-FirstCall/ — Stereotaxis, Inc. (Nasdaq: STXS) highlighted significant new additions to the body of evidence demonstrating exceptional clinical outcomes achieved with its NiobeÃ‚® Magnetic Navigation System in ventricular tachycardia (VT) ablation.
At the European Cardiology Society Annual Congress in Stockholm last week, the research team led by Dr. Tamas Szili-Torok from the Erasmus Medical Center in Rotterdam presented the first comparative trial in a prospective study of 64 consecutive VT patients, comparing Stereotaxis VT ablation to conventional, non-magnetic ablation. Acute success was achieved in 97% of the Stereotaxis VT ablation group versus 81% of the manual ablation group. Patients in the Stereotaxis VT group averaged 50% less x-ray exposure, and after a year, only 14% VT recurrence, versus a 50% recurrence rate among manual ablation patients. A remarkable 25% reduction in total procedure time was achieved in the Stereotaxis VT group compared to the manual group.
There were no major complications in the Stereotaxis VT group compared to one death in the non-Stereotaxis group, representing a 4% major complication rate.
“The use of Stereotaxis offers major advantages for the ablation of VT,” said Dr. Szili-Torok. “We have adopted a 100% utilization rule for our Stereotaxis lab for cardiac arrhythmias due to the significant benefits for our patients as well as for us as operators.”
Further, Dr. Arash Arya and colleagues from the University of Leipzig Heart Center in Leipzig, Germany published data from a series of 30 consecutive patients who were suffering from “VT storm,” which is three or more VT episodes in a 24 hour period that trigger a shock treatment from an implanted defibrillator device. While treating VT Storm is extremely challenging, Dr. Arya reported that 70% of the patients in this series were free from any VT episodes at nearly one year following cardiac ablation with Stereotaxis. The journal Pacing and Clinical Electrophysiology will publish Dr. Arya’s series in an upcoming issue. An early review of the abstract is available at http://www.ncbi.nlm.nih.gov/pubmed/20723092.
“VT ablation is extremely challenging and risky, yet remains a promising treatment option to reduce risks of sudden cardiac death,” said Michael P. Kaminski, Stereotaxis CEO and President. “Our magnetic navigation system’s unparalleled mapping precision, safety profile and ability to treat difficult areas of the heart have been proven by scientific studies from around the world to minimize these challenges for the delivery of an effective treatment.” We are proud to be on the cutting edge of VT treatment and excited to see Stereotaxis VT procedure volumes growing at three times the rate of manual VT procedures through the first half of this year. We are confident that Stereotaxis VT ablation is on a path to become the worldwide standard of care for VT treatment, bringing superior clinical benefits to both patients and caregivers.”
With 15% annual growth, VT ablation is among the fastest growing EP procedures. In 2010, VT ablation will reach approximately 30,000 procedures worldwide, representing approximately 20% of all complex EP procedures.
VT is a potentially life-threatening arrhythmia because it may lead to ventricular fibrillation, asystole, and sudden death. VT is one of the most challenging arrhythmia facing electrophysiologists due to complex anatomy, the sensitive nature of ventricular tissue, and potentially lethal outcomes. Catheter ablation of VT, one of the fastest growing EP procedures globally, requires the delivery of robust lesions for clinical success.
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of arrhythmias and coronary artery disease. The Stereotaxis system is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. The unparalleled clinical capability of Stereotaxis has driven more than 130 hospitals to adopt magnetic navigation for a growing number of complex ablation cases in all four chambers of the heart. Stereotaxis technology is now installed and used by 9 out of the Top 10 Best U.S. Heart Hospitals as ranked by U.S. News and World Report, and more than one third of the EP academic training centers in the United States have included Stereotaxis into their arrhythmia treatment laboratories. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe, Canada and elsewhere.
The Odyssey portfolio of products provides an innovative enterprise solution for integrating, recording and networking interventional lab information around the world. Odyssey Vision standardizes data integration for magnetic and standard interventional labs by enhancing the physician workflow through a consolidated display of multiple systems and eliminating the challenge of interacting simultaneously with many separate diagnostic systems. Odyssey Enterprise Cinema then captures a complete record of synchronized procedure data that can be viewed live or from a comprehensive archive of cases performed. Through its proprietary data compression technology, Cinema enables sharing of live and recorded procedure data via a laptop anywhere over a secure high speed Internet connection. Hospitals can also share procedures with other institutions using Odyssey Network Connect providing a global forum for defining clinical best practices across a broad spectrum of medical procedures.
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, continued acceptance for the Company’s products in the marketplace, the effect of global credit and economic conditions on the ability and willingness of customers to purchase our systems, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approval and return of the irrigated catheter to the market, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.
SOURCE Stereotaxis, Inc.