NATICK, Mass.--The U.S. Food and Drug Administration has cleared Boston Scientific Corp. to launch its new balloon catheters in the United States, according to a company release.
The Sterling Monorail and Over-the-Wire Balloon Dilation Catheter both come in a wide range of sized and were designed to be used in renal and lower extremity arteries as well as in dialysis fistula, Boston Scientific said.
The medical-device company added that the Sterling catheter can also be used in the carotid arteries in a pre- and post-dilation balloon.
"We have incorporated design elements from…our Maverick2 balloon catheter," said John Pederson, president of Boston Scientific's Peripheral Interventions Business. "Features such as the laser-formed, tapered tip are designed to facilitate crossing through the most challenging lesions, including tight stenosis and near occlusions."