Medtronic Stent Graft Chosen By FDA For Complex Thoracic Aneurysm Feasibility Study

Regulatory agency selects investigational medical device for endovascular treatment of thoracic aortic aneurysms involving branch vessel for early feasibility pilot program

 

June 22, 2012

June 22, 2012 –– The U.S. Food and Drug Administration (FDA) recently selected a stent graft being developed by Medtronic Inc. for an early feasibility pilot program that allows for “early clinical evaluation to provide proof of principle and initial clinical safety data.”

One of nine devices selected for the program, the Valiant Mona left subclavian artery (LSA) system is a stent graft designed to repair a descending thoracic aortic aneurysm encroaching on the LSA. The device is based on the market-leading Valiant Captivia Thoracic Stent Graft, which is approved by the FDA for treating aneurysms/penetrating ulcers and related conditions of the descending thoracic aorta without major surgery.

The international market leader in its product category, the Valiant Captivia Stent Graft is approved by the FDA for endovascular repair of aneurysms and penetrating ulcers of the descending thoracic aorta in patients with a non-aneurysmal aortic diameter in the range of 18 to 42 mm and non-aneurysmal aortic proximal and distal neck lengths greater than or equal to 20 mm.

For more information: www.medtronic.com