New Medtronic Stent Selected by FDA for New Accelerated Review Program The U.S. Food and Drug Admin

New Medtronic Stent Selected by FDA for New Accelerated Review Program
The U.S. Food and Drug Administration (FDA) has selected a stent graft being developed by Medtronic Inc. for an early feasibility pilot program that allows for “early clinical evaluation to provide proof of principle and initial clinical safety data.”

The in-the-works Valiant Mona LSA system is one of nine devices selected for the program. It is designed to repair a descending thoracic aortic aneurysm (TAA) encroaching on the left subclavian artery (LSA). It’s an updated version of the FDA-approved Valiant Captivia thoracic stent graft, a minimally invasive device that treats aneurysms, penetrating ulcers and related conditions of the descending thoracic aorta.

TAAs are dangerous bulges in the aorta, the body’s main artery, near its point of origin in the heart. Left untreated, the bulges can rupture, killing those suffering from the condition. A thoracic stent graft is a
tubular medical device that a physician delivers through a pre-loaded catheter inserted in the patient’s femoral artery. Once deployed, the stent graft conforms to the wall of the aorta, the body’s main
artery, creating a new path for blood flow that reduces pressure on the aneurysm and the risk of rupture.

“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,” said Tony Semedo, vice president and general manager of the company’s Endovascular Therapies business. “In fact, about 40 percent 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.”

Semedo explained that the Valiant Mona LSA could possibly eliminate the need for LSA bypass procedures. He said the company is pleased the device was selected for the FDA’s early
feasibility pilot program, which “demonstrates the agency’s understanding of the need for collaborative innovation.”

The FDA’s early feasibility program was introduced last year to encourage innovative devices. According to the guidance document, 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 (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) when such
information cannot readily be provided through additional nonclinical assessments or appropriate nonclinical tests. Data from early feasibility studies may guide device modifications.

The Valiant Mona Lisa LSA system fills the need for repairing TAAs in patients whose aneurysms are inaccessible by traditional methods. According to the Society for Vascular Surgery (SVS), an
estimated 40 percent of patients with descending thoracic aneurysms have insufficient seal zones for endovascular repair. The seal zone is the circumferential length of healthy aorta required to secure the placement of the stent graft across the aneurysm. Published reports show a higher rate of stroke and mortality associated with coverage of the LSA. Based on these reported adverse events, the SVS has recommended routine pre-operative re-vascularization to perfuse the LSA in patients who need elective endovascular repair where achievement of an adequate seal requires coverage of the LSA.