FDA Clears Stereotaxis Guidewire for Peripheral Chronic Total Occlusions

Conventional catheters are designed to be operated mechanically from their proximal or back end. They are necessarily stiff to allow for steering through a series of cables. In contrast, Stereotaxis’ proprietary catheters are controlled directly at their working end by a magnetic field and are extremely soft and flexible.

The company’s Magnetic Navigation System allows physicians to more effectively navigate catheters, guidewires and other magnetic interventional devices through the blood vessels and chambers of the heart to treatment sites and then to effect treatment.

This atraumatic design may reduce the risk of perforation or damage to heart tissue or vessel walls. Stereotaxis’ systems are currently used in the cardiac catheterization lab.

The System provides the physician with remote instrument control using a “point and click” or joystick-operated technology, which can be operated from beside the patient table, as in traditional interventional procedures, or from a room adjacent to the patient but outside the x-ray fluoroscopy field, minimizing radiation exposure.

On Wednesday, the company announced that it received FDA clearance to use its PowerAssert radiofrequency guidewire to cross chronic total occlusions (CTO) in the peripheral vasculature.

Commenting on the clearance, Dr. John Young, Director of the Ohio State University Medical Center said, “This will be the first CTO crossing device that can enable true intra-lesion steering, and I expect it to substantially improve the range of options for CTO treatment.”

Occluded or blocked arteries occur in patients with advanced peripheral arterial disease, and if left untreated can result in ulcerations and gangrene as well as significantly increased risk of limb loss and death. Eight to twelve million people have PAD, according to the American Heart Association.

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