MR Vascular Guidewire Cleared by FDA

Food and Drug Administration (FDA).

The disposable coil, measuring only 30-thousandths of an inch in diameter, produces extremely high-resolution images of the vascular wall that help doctors diagnose plaque in vessels such as renal arteries. Called Intercept-Vascular, the guidewire allows a doctor to obtain these high-resolution, cross-sectional images without exposing the doctor or patient to ionizing radiation or toxic contrast dye. The guidewire is the product of Surgi-Vision, Inc. (Columbia, MD, USA). The company has previously received FDA clearance for coils that image the esophagus, the urethra, and the prostate.

"It will enable physicians to not only assess the degree of vessel stenosis, but will also allow them to determine plaque content,” said Albert Lardo, Ph.D., medical director of Surgi-Vision. "Atherosclerotic plaque content is an important predictor of plaque instability or vulnerability, believed to be highly associated with adverse clinical events such as stroke and heart attack.”



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