Stereotaxis Magnetic Navigation System Used To Successfully Treat An Inoperable Congenital Heart Defect In A 10 Year Old Patient

Main Category: Cardiovascular / Cardiology
Article Date: 17 Jul 2008 - 2:00 PDT

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Stereotaxis, Inc. (Nasdaq: STXS) announced that the pediatric cardiology team at the Heart and Diabetes Center of North Reinland-Westphalia in Bad Oeynhausen, Germany, successfully performed a first-of-its-kind-procedure to treat pulmonary atresia in a 10-year old boy. The team performed the procedure with Stereotaxis' Niobe Magnetic Navigation System.

Pulmonary atresia is a congenital malformation of the pulmonary valve which obstructs the flow of blood from the heart to the lungs. As a result, blood is forced to flow to the lungs through a hole in the inner wall of the heart, known as a ventricular septal defect, and around a circuitous route through small, winding vessels. The disease severely limits the efficient transport of oxygen throughout the body.

This patient had failed a previous surgical attempt to correct the atresia because there were no vessels of adequate size or quality to utilize. After two conventional catheterization attempts, the Bad Oeynhausen team, lead by Dr. Nikolaus Haas, Director of the Catheterization Laboratory in the Department of Congenital Heart Defects at the Heart and Diabetes Center, used Stereotaxis' software to create a 3D model of the tortuous vessels that had replaced this patient's absent pulmonary artery. The Niobe Magnetic Navigation System then made it possible for the team to navigate a magnetic guidewire through the entire length of the difficult vessel and place a specialized stent that now permits increased blood flow from the aorta to the left lung, increasing the amount of oxygen that can be pumped around the body.

Fewer than 2 days after the procedure, the young patient was discharged from the hospital. Before the procedure, the patient was cyanotic, appearing blue due to insufficient oxygen supply, and could not walk 100 meters without running out of breath. Today, his color is good, and he is able to walk more than 1000 meters before needing to rest. Dr. Hass believes that the patient will experience still greater improvement after a second, planned procedure to improve blood flow to his right lung, and that the patient is well on the road to being able to participate in day-to-day activities, like walking to school and playing with friends.

"With the Stereotaxis technology, we are now able to help patients whose quality of life is extremely limited by severe congenital heart defects that have few viable treatment options," said Dr. Haas. "This patient nearly died during an earlier conventional procedure, and we thought we had exhausted our options to improve his quality of life. Based on this initial experience with the Stereotaxis System, we have already scheduled another patient with pulmonary atresia for this new procedure. In our current patient population alone there are at least 20 additional children with this disease who can benefit from the unique capabilities of the Stereotaxis technology."

"We are extremely gratified to see this young boy's life change so dramatically, and we applaud the ingenuity of Dr. Haas and his team," said Bevil Hogg, CEO of Stereotaxis. "This case underscores the value of the Niobe Navigation System as a platform for a broad range of interventional procedures beyond our core electrophysiology applications, and it is very rewarding to be part of such a groundbreaking application of our technology."

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 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 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 or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.

Stereotaxis, Inc.
http://www.stereotaxis.com