FDA Clears ZigiWire Access Guidewire System

December 19, 2014—Vascular Solutions, Inc. announced that the ZigiWire access support guidewire system has received 510(k) clearance from the US Food and Drug Administration. ZigiWire is designed to facilitate placement and exchange of catheters during peripheral diagnostic or interventional procedures. Vascular Solutions plans to launch ZigiWire in the United States in January 2015.

According to Vascular Solutions, the ZigiWire guidewire support systems employ an efficient method of establishing progressive and secure support wire access into most arterial vascular anatomy. Through any standard 0.038-inch-compatible catheter lumen, the interventionist advances a floppy-style lead wire for initial engagement of the target vessel, which is then followed by up to two additional wires to achieve the desired level of guidewire support.

Vascular Solutions will offer a two-wire and a three-wire version of ZigiWire. The two-wire version is designed for use in contralateral access cases in lower extremity vasculature. The three-wire version is designed to provide extra support in other peripheral anatomy procedures, such as gaining access into mesenteric or other vasculature that is tortuous in nature.

VadisWire Corporation developed the ZigiWire and manufactures it for Vascular Solutions. VadisWire was founded by interventional cardiologist William Gray, MD, of the Cardiovascular Research Foundation, and engineer and executive Ted Wulfman.

In Vascular Solutions’ press release, Dr. Gray commented, “By delivering small-diameter wires consecutively into the peripheral vasculature, ZigiWire allows an operator to more easily access the intended vessel. Several small wires in parallel provide the cable-type support required to deliver a range of larger sheaths and guiding catheters into challenging anatomy such as in the lower extremities and mesenteric vasculature.”