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’sValiant Mona LSA system developed torepair a descending thoracic aortic aneurysm encroaching on the leftsubclavian artery (LSA) has won an investigational device exemption.
FDA’s Early Feasibility Medical Device Clinical Studiesprogram, 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 howTony Semedo, vice president and generalmanager of the company’s Endovascular Therapies business, described the product in a news release.
Endovascular repair of thoracic aortic aneurysms involving branch vessels represents aclinical and technological challenge that Medtronic is committed to solving for thebenefit of physicians and patients alike.In fact, about 40 percentof these cases involve coverage of the LSA — and, therefore, often require surgicalbypass to preserve blood flow to the posterior brain and left arm.Our Valiant Mona LSA system could potentially obviate the need for LSA bypassprocedures, extending the benefits of endovascular repair without surgery to morepatients with thoracic aortic aneurysms.
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.