Medtronic Announces FDA Clearance And Market Availability Of The Reliant Stent Graft Balloon Catheter

Medtronic, Inc. (NYSE:MDT) today announced U.S. Food and Drug Administration 510(k) clearance and market availability for the Reliant Stent Graft Balloon Catheter, a multipurpose catheter used for temporary occlusion of large vessels and the expansion of vascular prostheses. The Reliant Stent Graft Balloon Catheter has been used in more than 9,000 endovascular stent graft procedures outside the United States since 2001.

Stent grafts are used during endovascular aortic repair (EVAR) to treat abdominal aortic aneurysms (AAA), one of the leading causes of death in the United States. The Reliant Stent Graft Balloon Catheter offers a working range of between 10-46 mm, the largest range of inflation diameters of any stent graft balloon catheter on the market. It also may be used during thoracic aortic aneurysm (TAA) repair, a similar treatment in the area above the abdomen, giving physicians more flexibility during EVAR procedures.

"The Reliant Stent Graft Balloon Catheter offers physicians a single solution for all their stent graft procedures," said Katie Szyman, vice president and General Manager of the Medtronic Endovascular business. "This balloon is versatile, has good vessel wall conformability, and firm expansion with minimal balloon overhang. This is important for patient recovery, as it may reduce the risk of vessel trauma sometimes seen with non-compliant balloons."

The balloon is made of a latex-free, polyurethane material and has a useable catheter length of 100 centimeters. 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.

Its clinical uses include sealing endoleaks by expanding the stent graft, removing creases from the graft material, and temporarily occluding blood flow in large vessels during EVAR procedures.