Vascular Solutions' GuideLiner Catheter Receives FDA Clearance

November 9, 2009—Vascular Solutions, Inc. (Minneapolis, MN) announced that it has received 510(k) clearance from the US Food and Drug Administration to launch the GuideLiner catheter in the United States. The device is a coaxial "mother-and-child" guide extension with rapid exchange convenience that provides backup support and selective deep intubation in challenging interventions.

According to the company, the GuideLiner catheter will be available in 6-, 7-, and 8-F sizes as part of Vascular Solutions' specialty catheter product line. Vascular Solutions will launch the device in the United States this month. In Europe, the GuideLiner received CE Mark clearance and was launched in October.

"Deep intubation of the GuideLiner catheter within a soft 6-F guide provides better backup support and is less traumatic than using stiff 7- and 8-F guides that were previously required in complex disease," commented Douglas Fraser, MD. "Furthermore, the soft and very flexible tip will often cross tortuous disease where a stent gets stuck, enabling delivery of stents and other equipment directly to the target lesion. The GuideLiner is as easy to insert as a standard rapid-exchange balloon catheter and has quickly become a routine part of my angioplasty practice."