Medtronic’s Valiant Mona LSA TEVAR Device Chosen for FDA’s Early Feasibility Pilot Program
June 21, 2012—Medtronic, Inc. (Minneapolis, MN) announced that its investigational device for the endovascular repair of a descending thoracic aortic aneurysm encroaching on the left subclavian artery (LSA) was selected by the US Food and Drug Administration (FDA) for participation in the FDA’s early feasibility pilot program. This program allows for early clinical evaluation to provide proof of principle and initial clinical safety data.
The device, called the Valiant Mona LSA, is based on the company’s Valiant Captivia thoracic stent graft, which is approved by the FDA for the endovascular treatment of aneurysms/penetrating ulcers and related conditions of the descending thoracic aorta in patients with a nonaneurysmal aortic diameter in the range of 18 to 42 mm and nonaneurysmal aortic proximal and distal neck lengths ≥ 20 mm.
In November 2011, the FDA published a draft guidance document to encourage and facilitate early feasibility studies of innovative medical devices in the United States. The pilot program will help test and refine the new approaches described in the draft guidance. The Valiant Mona LSA system is one of nine devices selected for the FDA program.
Medtronic cited the FDA’s guidance document to explain the role of the trial program:
“An early 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 (eg, 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.”
In a company press release, Tony Semedo, Vice President and General Manager of Medtronic’s Endovascular Therapies business, commented, “Endovascular repair of thoracic aortic aneurysms involving branch vessels represents a clinical and technological challenge that Medtronic is committed to solving for the benefit of physicians and patients alike. In fact, about 40% of these cases involve coverage of the LSA—and, therefore, often require surgical bypass to preserve blood flow to the posterior brain and left arm.”
“Our Valiant Mona LSA system could potentially obviate the need for LSA bypass procedures, extending the benefits of endovascular repair without surgery to more patients with thoracic aortic aneurysms,” Semedo continued. “We are pleased that the device was selected by the FDA for its early feasibility pilot program, which demonstrates the agency’s understanding of the need for collaborative innovation.”
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