Irish medical technology firm Medtronic has commenced a new feasibility study to assess the safety and effectiveness of the Valiant Mona LSA branch thoracic stent graft system.
Valiant Mona is an investigational medical device that has been designed to provide a complete endovascular solution for aortic aneurysms encroaching on the left subclavian artery (LSA).
Cleveland Clinic cardiothoracic surgeon Dr Eric Roselli has completed the first implant in the study, who is the national primary investigator of the study.
Dr Roselli said: "The use of an off-the-shelf stent graft system with a built-in branch has the potential to simplify this challenge by eliminating the routine requirement for surgical LSA bypass."
The company intends to enroll 24 subjects at up to seven sites in the US, which will characterize the safety and effectiveness of the investigational device acutely and at 30 days.
The Valiant Mona LSA system includes two pieces, including a graft for placement in the aneurysmal segment of the aorta and a branch graft for placement in the LSA.
Its two pieces fit together to exclude the aneurysm and maintain patency of the LSA in their deployed state. The main graft features a tapered opening or cuff that is oriented toward the LSA, while the branch graft fits inside the cuff and terminates in the LSA.
Medtronic aortic and peripheral vascular business aortic franchise general manager and vice-president Daveen Chopra said: "The start of this study represents another step forward in our efforts to develop standardized stent graft systems for the treatment of aortic disease involving branch vessels."
In 2012, Valiant Mona LSA system was studied as part of an early feasibility pilot program for medical devices initiated by the US Food and Drug Administration (FDA).
Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.