GORE® Tri-Lobe Balloon Catheter

The GORE® Tri-Lobe Balloon Catheter is a compliant, tri-lobed polyurethane balloon catheter designed to assist in dilating self-expanding endoprostheses in large diameter vessels. It features three polyurethane balloons mounted on a multi-lumen catheter shaft with radiopaque markers, allowing inflation without complete blockage of aortic blood flow. Available in two sizes with inflation ranges of 16-32 mm and 26-48 mm respectively.

The subject device maintains the same materials, design, and core functionality as the predicate device. The only technological differences are increases to the larger balloon's intended diameter (from 26-42 mm to 26-48 mm) and associated recommended inflation volume (from 12-25 mL to 12-35 mL), plus removal of a warning precluding use in the ascending aorta.

Not stated in this summary.

Substantial equivalence is supported by comprehensive bench testing (balloon burst, inflation volume determination, pushability, trackability, torque, fatigue, simulated use) demonstrating the device performs comparably despite the larger balloon specifications. Clinical data from the GORE® TAG® Thoracic Branch Endoprosthesis trial showed 44 subjects received the catheter in the ascending aorta and aortic arch with zero adverse events related to aortic rupture, dissection, balloon-related mortality, or Type III endoleak, validating both the removal of the ascending aorta warning and the increased inflation parameters.