510(K) clearance for Turnpike catheters

Minneapolis, Minnesota – Vascular Solutions Inc. officials announce that the company has received 510(k) clearance from the U.S. Food and Drug Administration for its Turnpike catheters, a new line of catheters designed for use in complex coronary and peripheral interventions. Vascular Solutions expects to launch the Turnpike catheters in January following clinical evaluations to occur in December.

“We are excited about the clearance of the Turnpike, which adds to our clinically important tools that started with our GuideLiner catheter for interventional physicians who treat complex cases,” said Howard Root, CEO of Vascular Solutions. “We view the Turnpike as one of our most important new product launches for 2015, and we believe this catheter will quickly become a substantial clinical and financial contributor to our product portfolio.”

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 two versions, a Soft Tip and a Hard Tip version, both of which advance over a 0.014" guidewire. The name Turnpike describes a unique feature of the catheter that by turning the catheter in a clockwise direction it will advance through the artery (i.e., down the pike).

The Soft Tip version extends the catheter’s braid and dual-layer coil into a soft, radiopaque distal tip, which following a non-tapered 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 terminates with a gold-plated, stainless steel distal tip. The Hard Tip version of Turnpike has been designed for use in cases in which a 0.014" 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.

The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. The catheters may be used to facilitate placement or exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.

Source: Vascular Solutions Inc.