Healthcare Industry News: Stereotaxis
News Release - May 18, 2006
Stereotaxis Announces Collaboration with Medtronic to Co-sponsor Clinical Study Investigating Role of Magnetic Navigation in Optimizing CRT ProceduresST. LOUIS, May 18 (HSMN NewsFeed) -- Stereotaxis, Inc. (Nasdaq: STXS ) announced today that they will co-sponsor a post-market, prospective, randomized outcomes-based clinical study to determine the role of magnetic navigation in LV lead placement optimization with Medtronic, Inc. (NYSE: MDT ).
The study will pair magnetically-guided LV lead implant techniques with select physiological parameters to measure response to pacing in multiple sites within the coronary venous system to determine the best pacing location. This optimized LV lead implant will be compared with conventional lead implant techniques to determine the difference in chronic response to optimized LV lead implant vs. conventional LV lead implants.
"Medtronic will contribute their significant expertise in the area of Congestive Heart Failure and we are extremely pleased to have a company of their stature and reputation as a partner in this study," said Bevil Hogg, President and Chief Executive Officer of Stereotaxis, Inc. "We look forward to exploring further collaborations with Medtronic in the area of CRT."
"This is an important study to advance the science of CRT and may lead to a change in the acceptable criteria for all CRT implants," said Carlo Pappone, M.D., Ph.D., of San Raffaele University Hospital in Milan, Italy, the lead investigator in the study.
The study is expected to begin enrollment in the second half of this year.
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.
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