FDA Clears Gopher Catheter by Vascular Solutions

 

July 3, 2007

Vascular Solutions Inc. announced that the FDA has granted 510(k) clearance for the Gopher support catheter, a catheter designed to assist in the passage of interventional devices through arterial lesions by utilizing a rotational force.

The Gopher catheter is designed designed to meet specific needs of physicians performing interventional percutaneous procedures in coronary and peripheral arteries, such as facilitating the passing of an angioplasty balloon in challenging coronary interventions.

The Gopher catheter will be available in both 3 French and 2 French sizes and is part of Vascular Solutions’ specialty catheter product line. Initial clinical evaluations of the Gopher catheter have already occurred, and The Gopher catheter is expected to launch in the third quarter of this year.