ST. LOUIS, March 1 /PRNewswire-FirstCall/ -- Stereotaxis, Inc. announced today that it has initiated the HEAL HF clinical trial, which is designed to evaluate the ability to magnetically navigate to multiple potential pacing sites and then optimize LV lead placement to treat heart failure. Professor Carlo Pappone M.D., Ph.D. is the first investigator to successfully enroll patients in the HEAL HF study. This international study is being conducted at five centers in Europe, Canada and the United States.
The case included the evaluation of seven pacing sites in the left ventricle, which exhibited significant differences from site-to-site in the hemodynamic response of the patient's heart, measuring cardiac function. The Stereotaxis system makes it feasible to quickly search for the optimal position by affording access to difficult to reach locations. The system stores previously accessed sites, providing physicians the capability and confidence that they will be able to return to the site that yields the greatest physiological response.
Bevil Hogg, CEO of Stereotaxis, stated, "Historically, up to 30 percent of heart failure patients do not improve after CRT implantation. We are very excited to be working with Medtronic, Inc. on this study, and we believe that our technology has the potential to improve patient response rates by optimizing lead placement."
"Stereotaxis gives the physician the ability to interrogate multiple vascular locations, potentially maximizing the benefit patients receive from their implantable device," said Professor Pappone.
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.
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, 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.
Contacts: Stereotaxis, Inc. Noonan Russo 314-678-6105 212-845-4242 Jim Stolze, Chief Financial Officer Ben Carmichael (investors) jstolze@stereotaxis.combenjamin.carmichael@eurorscg.com
Stereotaxis, Inc.CONTACT: Jim Stolze, Chief Financial Officer, Stereotaxis, Inc.,+1-314-678-6105 jstolze@stereotaxis.com; Investors: Ben Carmichael ofNoonan Russo, +1-212-845-4242, benjamin.carmichael@eurorscg.com, forStereotaxis, Inc.
