Medtronic's Mona LSA Branch Stent Graft System Studied in FDA Early Feasibility Pilot Program

April 29, 2013—Medtronic, Inc. (Minneapolis, MN) announced commencement of a clinical study of the company's Valiant Mona LSA branch stent graft system, designed for the treatment of aortic aneurysms encroaching on the left subclavian artery (LSA) with an entirely endovascular approach. The study is being conducted under the US Food and Drug Administration (FDA) early feasibility pilot program, which aims to encourage more early stage clinical research on new medical devices in the United States. The program includes nine medical devices from different companies.

Approved by the FDA under an investigational device exemption, the clinical study of Medtronic's Valiant Mona LSA branch stent graft system may enroll a total of seven patients at Carolinas HealthCare System in Charlotte, North Carolina, and the Cleveland Clinic in Ohio. Vascular specialists at the two sites recently performed the initial implants in the study.

According to Medtronic's announcement, the investigational device is based on the company's Valiant thoracic stent graft. Modifications include a branch cuff that accommodates the LSA branch graft. The Mona LSA device is part of the company's efforts to develop standardized stent graft systems to treat aneurysms throughout the aorta when the involvement of a branch vessel requires the stent graft to allow perfusion of critical organs or tissue.

“A standardized stent graft system that addresses the anatomical variability in thoracic aortic aneurysms involving the LSA could make this repair technique even less invasive for a large number of patients,” stated the study's primary investigator, Eric Roselli, MD, a cardiothoracic surgeon at the Cleveland Clinic, in the company's press release. “This trial is a first step toward developing more disease-specific and patient-specific devices to treat a very complex disease problem.”

Frank Arko, MD, a vascular surgeon and lead investigator at Carolinas HealthCare System's Sanger Heart & Vascular Institute added, “This endovascular treatment for aortic aneurysms provides an important alternative to open-chest operations. By eliminating the need for invasive surgeries, we should be able to reduce certain complications and hopefully improve outcomes for patients facing a life-threatening illness.”