The U.S. FDA recently 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 FDA is permanently under pressure from patient groups, clinicians, politicians and companies, claiming that what they see as its overly restrictive barriers to market entry are preventing helpful new technologies from reaching patients who may benefit from them. The agency has a couple of initiatives which may even be expanded in the future and appear to open its drawbridge to new technologies just a little bit. One is Humanitarian Device Exemption in which a specific, needy and limited patient group may be given access to a new and beneficial technology without the need for full approval. Another was kicked off in 2011, when the FDA published a draft guidance document to encourage and facilitate early feasibility studies of innovative medical devices. The resultant pilot program involves selection of nine devices whose entry criteria are that they are early in development (typically before the device design has been finalised), and to be tested for a specific indication (e.g., innovative device for a new or established intended use, marketed device for a novel clinical application).
According to FDA’s own guidance, the initiative is intended “to 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.”
Why this indication?
A thoracic aortic aneurysm (TAA) is a dangerous bulge in the body’s main artery near where it originates from the heart. When left untreated, a TAA can rupture, leading to an emergency situation in which extensive internal bleeding usually leads to death.
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.
In other words it’s a pretty intractable problem and the stent graft concept may be a helpful solution.
Why Medtronic’s product?
The Valiant® Mona LSA system is a stent graft designed to repair a descending thoracic aortic aneurysm encroaching on the left subclavian artery (LSA). The device is based on the market-leading 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 international market leader in its product category, the Valiant Captivia Stent Graft is approved by the FDA for endovascular repair of aneurysms and penetrating ulcers of the descending thoracic aorta in patients with a non-aneurysmal aortic diameter in the range of 18-42mm and non-aneurysmal aortic proximal and distal neck lengths ≥ 20mm.
“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.”
“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 added. “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.”
Source: Medtronic Inc.