FDA Clears Medtronic's Reliant Stent Graft Balloon Catheter

The FDA gave 510(k) clearance to Medtronic for its Reliant Stent Graft Balloon Catheter, a multipurpose catheter used for temporary occlusion of large vessels and the expansion of vascular prostheses.

Uses for the Reliant Stent Graft Balloon Catheter include sealing endoleaks by expanding the stent graft, removing creases from the graft material and temporarily blocking blood flow in large vessels during endovascular aortic repair (EVAR) procedures. It offers a working range of between 10 mm and 46 mm, and the latex-free, polyurethane balloon has a useable catheter length of 100 cm. The balloon catheter also offers the lowest profile of all large compliant balloons with an 8 French shaft, and is compatible with a minimum 12 French introducer sheath.

The device may also be used during thoracic aortic aneurysm repair, a similar treatment in the area above the abdomen, giving physicians more flexibility during EVAR procedures.