Medtronic (NYSE:MDT) announced on Thursday that a stent graft to treat thoracic aortic aneurysms is one of nine devices part of a pilot program at the U.S. Food and Drug Administration aimed to help establish clinical and safety profiles for novel devices.
As a result of this, Medtronic’s Valiant Mona LSA system developed to repair a descending thoracic aortic aneurysm encroaching on the left subclavian artery (LSA) has won an investigational device exemption.
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FDA’s Early Feasibility Medical Device Clinical Studies program, launched in November, allows manufacturers to test their devices on a small number of people — generally not more than 10 — before a final design or intended use has been decided. That is because these products cannot answer some questions simply based on nonclinical testing, but haven’t established a safety profile to be used, even as an investigational device, on a broad section of people.
In March, the FDA extended the program for another year and announced that it was no longer accepting applications. An FDA spokeswoman couldn’t immediately say which other eight devices have been accepted into the program.
For Medtronic, the inclusion of its Valiant device gives the company a chance to test the product to treat certain thoracic aneurysms without going the surgical route. Here’s how Tony Semedo, vice president and general manager of the company’s Endovascular Therapies business, described the product in a news release.
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 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.
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A Medtronic spokesman said that while the company has a prototype, the device is too early stage to know when it will do clinical studies and when it will file and application with the FDA.
