FDA Clears Vascular Solutions' Turnpike Catheters

December 1, 2014—Vascular Solutions, Inc. announced that it has received 510(k) clearance from the US Food and Drug Administration for its Turnpike catheters, which are designed for use in complex coronary and peripheral interventions. Vascular Solutions expects to launch the Turnpike catheters in January following clinical evaluations in December.

According to the company, the Turnpike catheters are single-lumen catheters with a shaft constructed from two layers of polymer that encapsulate both a braid and a dual-layer coil. The Turnpike is available in a soft tip and a hard tip version, both of which advance over an 0.014-inch guidewire. By turning the catheter in a clockwise direction, it will advance through the artery. The catheters may be used to facilitate placement or exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.

The soft tip version extends the catheter’s braid and dual-layer coil into a soft, radiopaque distal tip, which—following a nontapered, polymer-only section—gradually tapers to a smooth distal edge. The soft tip version has been designed for use in small and tortuous vessels in which the catheter’s flexible tip tracks over the guidewire around tight curves in the artery.

The hard tip version, which terminates with a gold-plated, stainless steel distal tip, has been designed for use in cases in which an 0.014-inch guidewire has advanced through a lesion but the advancement of any other device over the guidewire is difficult. The hard tip version is available in two configurations: one with a threaded distal tip designed to provide additional rotational advancement and one with a smooth distal tip for minimal friction during advancement, stated Vascular Solutions.