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First-in-Man Research on Endovascular Device Initiated as Part of FDA Program
Medtronic has announced the initial implants of its novel endovascular stent graft system at the Carolinas HealthCare System and the Cleveland Clinic.
The implants were among the first to be performed under the FDA early feasibility pilot program, which is designed to encourage more early-stage clinical research on new medical devices in the United States. The program includes a total of nine medical devices from different companies.
The stent graft system being tested (The Valiant Mona LSA) is designed to enable the repair of thoracic aortic aneurysms encroaching on the left subclavian artery (LSA) with an entirely endovascular approach.
The Valiant Mona LSA stent graft system is among the first to be implanted under the FDA Early Feasibility Pilot Program.
Image: Medtronic
“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,” Eric Roselli, MD, a cardiothoracic surgeon at the Cleveland Clinic and the study’s primary investigator, said in a press release. “This trial is a first step toward developing more disease-specific and patient-specific devices to treat a very complex disease problem.”
The clinical study, which is approved under an investigational device exemption by the FDA, may enroll a total of seven patients at Carolinas HealthCare System, Charlotte, and the Cleveland Clinic combined.
The investigational device is based on Medtronic’s Valiant thoracic stent graft, which has been used to treat approximately 45,000 patients worldwide since 2005 when it received a CE mark.