ST. LOUIS, Jan. 22 /PRNewswire-FirstCall/ -- Leading European electrophysiologists shared their initial positive experiences with Stereotaxis’ partnered magnetic irrigated catheter, used with its Niobe(R) Magnetic Navigation System, during the Boston Atrial Fibrillation Symposium which concluded this past Saturday, Stereotaxis announced today. The new catheter, the world’s first magnetic irrigated catheter, is being used by these clinicians with the magnetic navigation system to treat complex arrhythmias, including atrial fibrillation. The new catheter was developed by a partner of Stereotaxis and was launched in Europe in November. The U.S. Food and Drug Administration approved the catheter for mapping and ablation in the United States earlier this month.
At the Boston Symposium, several hundred assembled electrophysiologists heard from Prof. Michel Haissaguerre, MD, of the University Hospital of Bordeaux, France; Prof. Gerhard Hendricks, MD, PhD, of Universitat Herzzentrum in Leipzig, Germany; Prof. Karl-Heinz Kuck of AK St. Georg in Hamburg, Germany; and Prof. Carlo Pappone MD, PhD of San Raffaele University Hospital in Milan, Italy.
Preliminary data was presented from the first 107 procedures performed at 7 institutions using the new magnetic irrigated catheter, of which approximately 68% were to treat paroxysmal atrial fibrillation. Among these 107 cases, 90% acute success was achieved. However, at sites that reported performing more than 20 cases, the acute success rate rose to 95%. There have been no reported complications.
In particular, Prof. Haissaguerre described a patient who had suffered with chronic atrial fibrillation for 7 years despite several aggressive therapies, including a prior ablation procedure. He performed an ablation procedure using the Stereotaxis System with the magnetic irrigated catheter and successfully converted the patient into a normal heart rhythm. The patient has not had any recurrence of the arrhythmia since the successful magnetic procedure.
“I have been remarkably impressed by the performance of the Stereotaxis partnered magnetic irrigated catheter since the mid-November release in Europe,” said J. David Burkhardt, MD, FACC, and Chief Medical Officer of Stereotaxis. “In comparison with my experience at The Cleveland Clinic with the earlier introduction of the manual irrigated catheter, the safety profile and success rates are outstanding. The magnetic catheter has been able to achieve the difficult endpoints of numerous operators without the need of manual navigation or ablation. Clearly, the initial experience demonstrates the ability for this catheter to replace manual navigation and ablation in very complex arrhythmias. With the recent FDA approval and splendid EU results, I expect a very successful launch in the United States.”
Bevil Hogg, CEO of Stereotaxis, added, “We are delighted with the initial results of our partnered magnetic irrigated catheter in the treatment of complex arrhythmias, and expect that the European release of this catheter will soon be followed by the establishment of key reference sites in the U.S. using the magnetic irrigated catheter. Stereotaxis’ order rates and financial performance have, in the past, been linked to regulatory approval milestones, and we are confident that, once again, when our partnered irrigated catheter is in use at key reference sites in the U.S. we will experience a positive turning point in our sales ramp. Our partner has indicated to us that this project is of the highest priority to them, and that they will be vigorously taking all the necessary steps to ensure a smooth, safe and expeditious launch in the United States.”
About Stereotaxis
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 Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guide wires 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 guide wire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada. The magnetic irrigated catheter is not approved for the treatment of atrial fibrillation in the United States.
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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, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, 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 we will recognize revenue related to our 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 our 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.
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