Stereotaxis Announces Positive Results from First 50 Clinical Procedures Performed with New Niobe ES™ System
ST. LOUIS, Jan. 10, 2012 /PRNewswire/ -- Stereotaxis, Inc. (STXS) today announced the completion of the first 50 clinical procedures using the Company's new Niobe ES" system to treat patients with a variety of complex cardiac arrhythmias. A majority of the first 50 cases were performed to treat atrial fibrillation (AF), the most common type of cardiac arrhythmia(1). Positive initial results with the Niobe ES system in Europe demonstrate that the average time for completion of mapping and ablation for the initial AF patients was 69 minutes. The data will be featured at the Boston Atrial Fibrillation Symposium 2012 to be held on January 12-14, 2012.
The Epoch" platform, which encompasses the Niobe ES system, is the Company's new generation comprehensive solution for the electrophysiology (EP) laboratory. It is designed to improve efficiency with a fully-remote, networked and modular robotic, magnetic system that enables greater surgical precision and improved catheter control while reducing the risk of complications. Stereotaxis began initial shipments of the Epoch platform in mid-December 2011, including six system upgrades from the Niobe® II navigation system at leading medical centers in the United States and Europe.
Professor Carlo Pappone of Villa Maria Cecilia Hospital, Cotignola Italy, said, "My vision was to click on the map and for the catheter to quickly and precisely move to that spot. Today with the Epoch platform, this is a reality. I believe the Epoch platform is one of the most important innovations for the EP practice to date. With the Epoch technology all physicians can successfully and consistently perform high quality AF procedures with the assurance of superior patient care."
THE HEART HOSPITAL Baylor Plano in Plano, Texas was the first North American site to install the new Epoch platform, and the first hospital in the world to perform an EP procedure using the new system.
"Interventional physicians want to leverage advanced technology that minimizes surgical risks to the patient while increasing the likelihood of a favorable outcome," said Brian DeVille, M.D., FACC, eletrophysiologist on the medical staff at THE HEART HOSPITAL Baylor Plano. "The new Niobe ES system will enable electrophysiologists on the medical staff to deliver therapy in a precise manner, while reducing X-ray exposure and procedure time for our patients."
"The initial feedback and interest in our new Epoch platform has been very favorable," said Michael P. Kaminski, President and CEO of Stereotaxis. "We look forward to continuing to build on the momentum of this milestone and have commitments for 12 additional system upgrades to Niobe ES which will be installed over the next few months."
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 coronary artery disease and arrhythmias. The Niobe® Remote Magnetic Navigation 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 and reduced x-ray exposure.
Stereotaxis' Odyssey" portfolio of products provides an innovative enterprise solution for integrating, recording and networking interventional lab information within hospitals and around the world. Odyssey" Vision integrates data for magnetic and standard interventional labs, enhancing the physician workflow through a consolidated display of multiple systems and eliminating the challenge of interacting simultaneously with many separate diagnostic systems. The Odyssey Cinema" Studio then captures a complete record of synchronized procedure data that can be viewed live or from a comprehensive archive of cases performed. Odyssey" solution then enables hospitals to efficiently share live and recorded clinical data anywhere around the world to attract patients and promote collaboration.
The core components of the Stereotaxis systems have received regulatory clearance in the U.S., Europe, Canada and elsewhere.(1) Niobe ES is cleared for the US but is not approved for treatment for atrial fibrillation. For more information, please visit www.stereotaxis.com and www.odysseyexperience.com.
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 of the Company's products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase our systems and the timing of such purchases, our continued access to capital and financial resources, including our ability to negotiate financing and lending arrangements on terms that are acceptable, the outcome of various shareholder litigation recently filed against us, competitive factors, changes resulting from the recently enacted healthcare reform in the U.S., including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, 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, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.
SOURCE Stereotaxis, Inc.