Patient Resources

Arrhythmia

The rhythmic beating of the heart results from the transmission of electrical impulses through the heart. When these electrical impulses are mistimed or uncoordinated, the heart fails to function properly, resulting in complications that can range from symptoms of fatigue and palpitations to stroke or sudden death. Over five million people in the U.S. currently suffer from the resulting abnormal heart rhythms, which are known as arrhythmias or irregular heartbeats

Heart Failure

In heart failure, the muscles on either side of the heart beat out of synchronization. This means that instead of efficiently pumping blood from the heart to the body when the heart "beats", the heart ejects only a fraction of the blood it contains and the rest pools in the heart, causing swelling of the heart and a debilitating deficiency of oxygen in the patient's body. The pooling of blood in the heart can also lead to formation of clots followed by stroke or sudden cardiac death.

Vascular Disease

Nearly a half million people die annually from coronary artery disease, a condition in which the formation of plaque in the coronary arteries obstructs the supply of blood to the heart, making this the leading cause of death in the U.S. Despite various attempts to reduce risk factors, each year over one million patients undergo interventional procedures in an attempt to open blocked vessels and another a half million patients undergo open heart surgery to bypass blocked coronary arteries.

Arrhythmias

I. Magnetic Navigation Treatment

The Stereotaxis Magnetic Navigation System is particularly well suited for the diagnosis and treatment of both common and complex arrhythmias, as successful treatment requires precise catheter positioning, often in hard to reach regions of the heart, which can be more consistently achieved using computerized, magnetic navigation.

Traditional techniques are challenging for physicians because they require very precise manual orientation of a relatively stiff catheter within potentially complex heart chamber anatomy. The goal of Stereotaxis' technology is to contact the wall of the heart in an optimal way. Softer, more flexible catheters may reduce the chance of distorting or damaging the heart wall. By combining the benefits of precise, computer-aided magnetic guidance with gentle catheter contact, Stereotaxis believes that it has the potential to enable softer, safer interventional procedures with better outcomes and shorter patient recovery times.

The Stereotaxis Magnetic Navigation System enables very precise, computerized control of the working end of the catheter combined with comprehensive integration of diagnostic imaging information. The objective is to provide:

• Improved safety and outcomes for patients being treated for both common and complex arrhythmias
• Least invasive treatment of complex arrhythmias with shorther procedures, brief hospital stays and faster recovery times
• Increased likelihood that patients with highly complex arrhythmias, such as atrial fibrillation, can find interventional treatment and be successfully cured.

II. Non-Magnetic Treatments

Conventional therapy for irregular heartbeat usually begins with a specific type of medicine called an anti-arrhythmic drug. Drug therapies usually work in the beginning but often lose their effectiveness over time. Many of these drugs have significant side effects such as breathing problems, stomach problems, and discoloring of the skin.

For patients who fail or cannot tolerate these drugs, catheter ablation is usually the next step in treating irregular heartbeats. In an ablation procedure, the diseased tissue in the heart that is causing the arrhythmia is destroyed using an energy source such as radiofrequency delivered by a catheter that is threaded through the groin up to the heart. Prior to performing an electrophysiology ablation, a physician typically performs a diagnostic procedure in which the electrical signal patterns of the heart wall are "mapped" to identify the heart tissue generating the aberrant electrical signals. Following the mapping procedure, the physician may then use an ablation catheter to disable the diseased electrical path, restoring the heart to its normal rhythm.

For certain patients with chronic severe arrhythmia or who have failed a catheter ablation, surgical treatment may be necessary. In surgical treatment, a large incision or a series of operating "portals" are created and surgical instruments are inserted into the chest. The diseased areas of the heart are disabled using either surgical incisions or an energy source. In these cases, small portions of the heart may actually be amputated in order to prevent complications such as stroke

Heart Failure

I. Magnetic Navigation Treatment

The Stereotaxis Magnetic Navigation System is particularly well suited to assist the physician in positioning the pacing lead on the left side of the heart. By enabling precise, computerized magnetic control of the tip of the guidewire, magnetic navigation can provide the physician with the ability to access and evaluate multiple locations in the heart to determine the best place to put the CRT lead, thus potentially improving patient outcomes.

Stereotaxis' magnetic CRT procedures bring precise direct control of the working end of the guidewire to potentially provide the following benefits:

• Increased likelihood that eligible patients can be successfully treated interventionally
• Shorter, simpler CRT procedures with better outcomes and less use of ionizing contrast
• Optimal lead placement resulting in better long term response rates

II. Non-Magnetic Treatments

Heart failure is a chronic disease that requires intensive treatment for the rest of a patient's life. Patients with heart failure are generally placed on two or more medications, such as beta blockers or angiotensin converting enzyme (ACE) inhibitors. These medications help to manage heart failure, although hospitalization is often required when symptoms become more severe.

In about half of heart failure patients, the left and right sides of the left ventricle of the heart do not contract at the same time. Cardiac resynchronization therapy (CRT), or bi-ventricular pacing, involves using a guidewire threaded through the groin to place a pacemaker lead into the coronary venous system of the heart to help "resynchronize" the heartbeat. These devices have been shown to improve patients' survival and quality of life by enabling the heart to pump more effectively and regularly. Many patients can benefit from CRT and return to normal lifestyles. However, roughly 30% of patients do not respond to this therapy, often due to the difficulty in placing the pacemaker lead into an optimal location.

Patients whose condition continues to worsen may require surgery. These procedures may include the implantation of a ventricular assist device (VAD), which is an external pump to help the heart pump blood to the body. Heart transplant may be required for patients who do not respond to drug therapy or surgical intervention.

Coronary Artery Disease

I. Magnetic Navigation Treatment

The Stereotaxis System can bring substantial benefit to the subset of complex interventional cardiology procedures, particularly those that include:

• Complex Lesions - Treatment of complex lesions is generally more problematic due to the difficulty in steering a wire through them. Because the magnetic navigation provides precise, computerized control of the working tip of a wire, it can enable physicians to more easily locate small openings in, and to advance a wire across, these lesions.
• Tortuous Anatomy - Some interventional procedures require physicians to navigate a wire through a series of very sharp turns in the patient's vasculature. Navigating through so-called "tortuous" anatomy using manual interventional techniques can be very time consuming and may be impossible. Precise magnetic navigation, along with computer-generated "roadmaps," can help physicians steer wires through these difficult winding blood vessels.
• Small Vessels - A number of medical studies report that diabetic patients usually comprise about 20 to 30% of U.S. hospital's interventional procedure volume. These patients generally have smaller vessels, making guidewire navigation extremely difficult. We believe that these patients can benefit significantly from the improved precise navigation enabled by the Stereotaxis system.

II. Non-Magnetic Treatments

The most common procedure for unblocking the coronary arteries is commonly referred to as percutaneous coronary intervention or "PCI." A typical manual PCI procedure begins with the physician making a small incision into the patient's upper leg. A thin wire is inserted into a blood vessel and threaded up through the blocked area of the coronary artery. A delivery catheter that has a small balloon and a stent on its tip is slipped over the wire and positioned at blocked area. The balloon is inflated and the stent is expanded so it flattens the plaque against the artery wall and forms a scaffold to hold the artery open.

Most PCI procedures are relatively simple and can be completed in 30 minutes or less. Approximately 15% of these procedures, however, involve difficult anatomy or disease and therefore require longer procedure times and may have sub-optimal outcomes.

Some patients who have very complex coronary artery disease or who have failed PCI may be treated with an open heart surgery called coronary artery bypass grafting or "CABG." In CABG procedures, a blood vessel is harvested from another area of the body (usually the leg) and is surgically sewn into the diseased coronary artery to effectively bypass the clogged vessel. This usually required a large surgical incision where the breastbone is intentionally fractured in order to access the heart.

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