Minnesota’s Vascular Solutions gets FDA clearance for catheter

MINNEAPOLIS, Minnesota –- Device company Vascular Solutions Inc. has received clearance from the U.S. Food and Drug Administration to market its GuideLiner catheter — a device the company thinks could eventually net more than $10 million in annual sales.

The company says the GuideLiner can push deeper and more effectively into a heart during surgeries in which physicians use balloons to clear blockages — a procedure known as percutaneous coronary intervention. Vascular Solutions expects to begin selling the device in the United States this month. In Europe, sales and clinical use of the device began in October after receiving approval there earlier this year.

This is one of four devices Vascular Solutions expects to launch in the final months of 2009. It recently compared the revenue potential of the GuideLiner with that of the ProntoV3, one of the company’s “extraction” catheters that has accounted for roughly three-quarters of its $12.3 million in sales from that category so far this year.

The company’s product line consists of five major categories: hemostat products, clot removal catheters, vein products, specialty catheters and access products. The GuideLiner is one of nine specialty catheters.

So far this year, the company has reported net income of $3.76 million and sales of more than $50.2 million through Sept. 30.