Medtronic Presents First-in-Human Data on Valiant Mona LSA Stent Graft System

November 20, 2013—Medtronic, Inc. (Minneapolis, MN) announced that the company's Valiant Mona LSA branch thoracic stent graft system for the treatment of the left subclavian artery (LSA) has demonstrated proof of concept in a first-in-human study. The study, which is being conducted under the US Food and Drug Administration's (FDA) “Innovation Pathway” early feasibility pilot program, enrolled seven patients from the United States. The data were presented at the 2013 VEITH Symposium in New York, New York.

Medtronic reported that acute procedure results from all seven patients revealed 100% technical success and 100% patency in both the main and branch stent grafts. There were no type I or III endoleaks.

Frank Arko, MD, a vascular surgeon at Carolinas HealthCare System's Sanger Heart & Vascular Institute in Charlotte, North Carolina is one of the study's two United States investigators. In Medtronic's press release, Dr. Arko commented, “The initial results of this early feasibility study are extremely encouraging. This new technology could potentially minimize the need for invasive surgery and extend the benefits of endovascular repair without additional surgery to more patients with thoracic aortic aneurysms.”

According to Medtronic, the Valiant Mona LSA system is designed to enable endovascular repair of thoracic aortic aneurysms encroaching on the LSA vessel by excluding the aneurysm from blood flow while maintaining perfusion of the LSA.

The Mona LSA is based on the Valiant Captivia thoracic stent graft. The investigational system features a branch cuff that accommodates the LSA branch graft. Its design eliminates the routine requirement for surgical LSA bypass, which proves necessary after about 40% of thoracic aortic aneurysm cases in which coverage of the LSA is required to achieve a seal zone with the stent graft.

Medtronic noted that the FDA approved the study under an investigational device exemption to demonstrate the proof of principle, and the initial clinical safety of the first device of its kind to undergo clinical evaluation in the United States.

Eric Roselli, MD, a cardiothoracic surgeon at the Cleveland Clinic in Cleveland, Ohio, is the study's national primary investigator. Dr. Roselli stated, “Thoracic aortic aneurysms involving branch vessels such as the LSA can be particularly challenging to treat. The Valiant Mona LSA system could help address an unmet need in the treatment of thoracic aortic aneurysms. This is clearly reflected in the FDA's decision to help advance the development of this new therapy.”

In April 2012, Medtronic announced that the Valiant Mona LSA system was the first of nine devices selected for evaluation as part of the FDA's Innovation Pathway, a pilot program intended to encourage early stage clinical investigation of new medical devices in the United States.

The beginning of study enrollment was announced in April 2013.