FDA Clears Vascular Solutions for Turnpike Catheters
Washington, DC - Vascular Solutions is looking at a January U.S. launch of its Turnpike catheters, following FDA 510(k) clearance on Nov. 25. The catheters, for use in complex coronary and peripheral procedures, will first undergo clinical testing this month, the company said Monday.
The Turnpike catheters are so named because of a feature that allows them to advance through the artery when it is turned clockwise, as in “down the pike,” the Minneapolis devicemaker explains. The single-lumen catheters have a shaft consisting of two layers of polymer that encapsulate a braid and a dual-layer coil. They come in both soft tip and hard tip versions that advance over a 0.014" guidewire.
The soft tip version is intended for use in small and twisting vessels, while the hard tip catheters are for advancing devices over the guidewire. The latter comes in two configurations — a threaded distal tip to provide additional rotational advancement and a smooth tip for minimal friction, the company says.
CEO Howard Root called the Turnpike “one of our most important launches” in the coming year. “We believe this catheter will quickly become a substantial clinical and financial contributor to our product portfolio.”
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