Conventional Interventional Treatment

Stereotaxis Value

Stereotaxis Solution 
 

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.

Blockages within a coronary artery, often called lesions, are categorized by degree of obstruction as partial occlusions, non-chronic total occlusions and chronic total occlusions (CTO). Lesions are also categorized by the degree of difficulty with which they can be opened as simple or complex.

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Unblocking the coronary arteries through guidewire-based surgery, commonly referred to as percutaneous coronary intervention (PCI), is often the preferred solution for a patient needing some form of surgical treatment for complex coronary artery disease. This is because these procedures are significantly less invasive when contrasted with the alternative, which is coronary artery bypass graft (CABG) surgery. Patients with complex or multi-vessel coronary artery disease are often referred to CABG rather than being treated with PCI procedures because of limitations in traditional cath lab technology relating to precise instrument control and image integration in complex cases.

A typical manual PCI procedure:

1. Begins with the physician making a small incision into the femoral artery in the patient’s upper leg.
2. A thin wire is inserted and then pushed and twisted manually by the physician from the external end of the device in order to attempt threading of the device through the vasculature of the patient to the treatment site in the coronary artery and then across the site of the vessel narrowing or blockage.
3. A delivery catheter that has a small balloon and a stent on its tip is slipped over the guidewire and advanced so that the balloon and stent are positioned at the vessel narrowing.
   The balloon is inflated and the stent is expanded so it flattens the plaque against the artery wall and locks in place to form a scaffold to hold the artery open.
4. The guidewire and delivery catheter are removed from the patient and the stent remains in the patient, effectively propping open the newly cleared vessel.
   The incision in the patient’s leg is closed with a few stitches.
   
   

 It is estimated that approximately 15% of these interventional cardiology procedures currently being performed are complex and therefore require longer procedure times and may have sub-optimal outcomes.

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

• Complex Partial or Total Occlusions. Treatment of these complex lesions is generally more problematic due to the difficulty in steering and pushing a guidewire through them. Because the Stereotaxis Magnetic Navigation System provides precise, computerized control of the working tip of a guidewire, it can enable physicians to more easily locate small openings in, and to advance a guidewire across, these lesions. The ability to cross complex lesions such as chronic total occlusions has grown increasingly important due to the effectiveness of drug eluting stents in treating these lesions. Since approximately one-fifth of patients referred for bypass surgery have chronic total occlusions, we believe a significant number of patients could be treated interventionally instead of surgically with the use of the Stereotaxis Magnetic Navigation System.

• Tortuous Anatomy. Some interventional procedures require physicians to navigate a disposable interventional device through a series of sharp turns in the patient's vasculature. Navigating through tortuous anatomy using manual interventional techniques can be very time consuming and physicians often cannot reach the lesion or manipulate the balloon or stent across the lesion once it has been reached. Because the system allows the working tip of disposable interventional devices to be precisely oriented regardless of the number of turns that have occurred, our technology allows physicians to more effectively navigate these devices through complex vasculature and deliver balloons and stents to treatment sites for therapy.

• 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, which often contain longer lesions with more diffusely distributed blockages, as well as tortuous anatomy, making guidewire navigation and stent delivery extremely difficult. We believe that these patients can benefit significantly from the improved disposable interventional device navigation enabled by the Stereotaxis Magnetic Navigation system.

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Stereotaxis’ magnetic computerized interventional cardiology solutions are designed to bring precise, direct control of the working end of interventional devices, and comprehensive integration of imaging information. The objective is to provide:

• Improved safety and outcomes for patients being treated for CTOs and other complex occlusions or those with tortuous anatomy or small vessels
• Least invasive treatment of complex coronary disease with shorter procedures, brief hospital stays and faster recovery times
• Increased likelihood that patients with such conditions can be treated interventionally with PCI, rather than through highly invasive coronary artery bypass graft surgery, or CABG

For more detailed information, consult your physician or click on the related links.

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