ST. LOUIS, March 6 /PRNewswire-FirstCall/ -- Stereotaxis, Inc. (Nasdaq: STXS - News) announced today that clinicians at two centers in the United States have performed successful cardiac ablation procedures with the NAVISTAR® RMT THERMOCOOL® catheter since the announcement of its approval by the U.S. Food and Drug Administration on February 26.
In the first procedure with the magnetic irrigated catheter, Dr. Andrea Natale, Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas, successfully treated a 65-year old male with persistent left-sided abnormal heart rhythm.
“This was a very complicated case,” said Dr. Natale. “The procedure was flawless, and the patient is doing extremely well. We are very pleased with the performance of the magnetic irrigated catheter. Now that it is available, we expect to use the Remote Magnetic Navigation System routinely to treat complex arrhythmias. The power of the magnetic irrigated catheter together with the precision of the Stereotaxis System represents a significant improvement in the management of complex arrhythmias.”
In a separate case, Dr. David Tschopp, electrophysiologist at The Heart Hospital of Austin, treated a 72-year old male patient with atrial flutter.
“The performance of the magnetic irrigated catheter was exceptional,” said Dr. Tschopp. “We were able to deliver the necessary therapy and the patient is doing extremely well. I believe that the combination of remote magnetic navigation with the irrigated catheter will have the greatest, most immediate impact on treating complex left sided ablations. It is exciting for this tool to be available to the millions of people who have this disease.”
Prior to FDA approval, Dr. Peter Weiss, MD MSc at Intermountain Medical Center in Salt Lake City, received a compassionate use exemption to treat a patient suffering from incessant premature ventricular contractions (PVCs) that accounted for over 30% of his heart beats each day. After treatment with the magnetic irrigated catheter, the patient’s PVCs were reduced to less than 5% of his total heart beats. The patient had failed medications and two previous attempts at catheter ablation.
“The details of our case at Intermountain demonstrate the full power of an irrigated catheter combined with the precision of magnetic navigation,” said Dr. Weiss. “We were able to maneuver the catheter into very difficult-to-reach anatomy, achieve excellent tissue-catheter contact, and successfully treat this complicated patient where other treatments had failed. This has been an extremely gratifying case and we look forward to broader and more consistent application of the magnetic irrigated catheter for complex cases at our Center going forward.”
“Everyone at Stereotaxis has been preparing for the introduction of the magnetic irrigated catheter in the U.S.,” said Mike Kaminski, Stereotaxis President and CEO. “With these first cases we have begun with our partner a phased rollout to our installed base of Niobe systems and we are working very diligently to be certain each center has the training and resources it needs to deploy the catheter with success. We’re looking forward to seeing a broader presentation of clinical experiences at the Heart Rhythm Society’s annual meeting in May.”
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 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 core components of the Stereotaxis System have received regulatory clearance in the U.S., Europe, and Canada and elsewhere.
About Forward-Looking Statements
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.
