Medtronic's Valiant Mona LSA stent graft system will be 1 of 9 devices selected for an early clinical evaluation program by the FDA.
The Fridley, Minn.-based med-tech titan's Valiant Mona LSA system will be part of a feasibility pilot program with the federal watchdog agency that allows for "early clinical evaluation to provide proof of principle and initial clinical safety data," according to a press release .
The stent graft, which is designed to repair a descending thoracic aortic aneurysm encroaching on the left subclavian artery, is based on the 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 feasibility study is a "limited clinical investigation of a device early in development, typically before the device design has been finalized, for a specific indication (e.g., innovative device for a new or established intended use, marketed device for a novel clinical application). It may be used to evaluate the device design concept with respect to basic safety and device functionality in a small number of subjects (generally fewer than 10 initial subjects) when this information cannot be readily provided through additional nonclinical assessments or appropriate nonclinical tests are unavailable. Information obtained from an early feasibility study may guide device modifications," according to the agency.