Volcano gets FDA, CE Mark OK for IVUS catheter

Intravascular ultrasound developer Volcano announced that it has received both the CE Mark and 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new Visions PV.035 digital intravascular ultrasound imaging (IVUS) catheter.

The new catheter incorporates new centimeter markers to facilitate length measurements important for selecting treatment devices. The markers will enable radiologic technologists to reduce the amount of contrast agent needed while performing a procedure, according to the company.

The Visions PV.035 catheter also features a longer connector length to improve procedural flexibility, a softer, more rounded tip with a lower entry profile, and GlyDx hydrophilic coating for delivery through tortuous anatomy.

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