Vascular Solutions Inc has received 510(k) clearance from the US Food & Drug Administration for the Langston dual lumen pigtail catheter. The Langston catheter is a two-lumen diagnostic catheter indicated for use in the simultaneous measurement of pressures from two locations in the arterial system. Receipt of the 510(k) clearance will allow sales of the Langston catheter to commence in the US through Vascular Solutions' direct sales force.

"This clearance and our impending launch of the Langston catheter continue Vascular Solutions' strategy of delivering clinically unique products for Interventional Cardiology and Interventional Radiology," commented Howard Root, CEO of Vascular Solutions. "The Langston catheter offers simultaneous accuracy and precise responsiveness in measuring intra-arterial pressure gradients. We estimate that the market opportunity for this unique catheter is approximately $10 million annually, and that our Langston catheter is the only pigtail catheter available on the U.S. market today that can be used to simultaneously measure differential intravascular pressures," Root added.

Vascular Solutions Inc is a medical device company that focuses on developing unique solutions for unmet clinical opportunities within Interventional Radiology and Interventional Cardiology. New products introduced in the second half of 2003 include the Vari-Lase endovenous laser procedural kit for the treatment of varicose veins, the D-Stat Dry haemostatic bandage for the rapid control of topical bleeding, the D-Stat Radial haemostat band for the control of bleeding following catheterizations utilizing the radial artery in the wrist, and the Pronto extraction catheter for the mechanical extraction of soft thrombus.