ST. LOUIS, Feb. 23, 2011 /PRNewswire/ -- Stereotaxis, Inc. (Nasdaq: STXS) announced today the first-ever use of its Niobe® Magnetic Navigation System in a renal artery ablation procedure for the treatment of chronic hypertension that was not treatable with medication. This procedure was performed by Petr Neuzil, MD, PhD, Head of Cardiology and Director of the Cardiac Arrhythmia Service at the Na Homolce Hospital in Prague, Czech Republic.
The patient was considered at high risk, having previously suffered both a massive heart attack and a stroke. He had been treated for hypertension for 8 years and had an average blood pressure during the day of 182/94 and 166/85 during the night despite treatment with five different medications. Using an irrigated magnetic catheter and an advanced electroanatomic mapping system, Prof. Neuzil was able to accurately map both left and right renal arteries and deliver precise lesions to disengage the sympathetic nerve endings. A follow up visit at 3 months after the procedure demonstrated that this patient's average blood pressure had been reduced to 153/78 during the day and 148/75 at night.
An increase in activity of the sympathetic nerves leading to the kidneys is a key factor in the development of hypertension. The consequences of this increased nerve activity include sodium and water retention, increased enzyme release, and a change in the blood flow to the kidneys, all of which are associated with an increase in blood pressure. Using advanced catheter navigation techniques, interventional physicians are able to disable the sympathetic nerves by delivering bursts of radiofrequency energy to the inside of the renal arteries. This technique, called "denervation," has been shown to significantly reduce blood pressure and minimize or eliminate the need for medication.
"Stereotaxis' integrated technology represents a potentially significant advance in the ability to perform renal denervation procedures," said Prof. Neuzil. "With the combined capability of advanced mapping and precise magnetic navigation, I was able to identify the target tissue and safely deliver low-energy therapeutic lesions with minimal need for contrast and radiation."
"Hypertension, which affects approximately 1 of every 4 adults worldwide, represents a significant healthcare burden," said Michael P. Kaminski, President and Chief Executive Officer of Stereotaxis. "For those patients who do not respond to medication and are good candidates for ablative therapy, we believe Stereotaxis has the potential to provide an innovative solution to help their physician deliver a definitive treatment to help control their high blood pressure."
It is estimated that nearly one billion people worldwide suffer from hypertension. Renal denervation to treat severe hypertension is a novel use of Stereotaxis magnetic navigation in its current commercial configuration that requires further evaluation. Prof. Neuzil's study clearly supports the feasibility of this technique and provides momentum for future investigation.
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, shorter procedure time 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. 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. Odyssey™ then enables hospitals to efficiently share live and recorded clinical data anywhere around the world to maximize referrals and promote collaboration.
The core components of the Stereotaxis systems have received regulatory clearance in the U.S., Europe, Canada and elsewhere. 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, 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.
Hypertension Statistics Reference: The Lancet, Volume 365, Issue 9455, Pages 217 - 223, 15 January 2005
SOURCE Stereotaxis, Inc.