|Medtronic is developing a version of its Valiant stent graft for the left subclavian artery.--Courtesy of Medtronic|
Medtronic ($MDT) is touting some positive early data on a stent graft that could expand the patient population for surgery-free endovascular repair, taking advantage of a speedy new FDA pathway set aside for innovative devices.
The Valiant Mona LSA is designed to repair thoracic aortic aneurysms in the left subclavian artery, cordoning off affected tissue without blocking blood flow in a tricky part of the vasculature. In a first-in-human study on 7 patients, the device charted 100% clinical success and 100% patency with no type I or III endoleaks in the stent graft. The early-stage U.S. trial is part of the FDA's new Innovation Pathway, designed to provide a quicker trip to the market for devices that address unmet public health needs.
If eventually approved, Medtronic's device would eliminate the need for now-routine LSA bypass surgery, extending the benefits of minimally invasive repairs to an underserved patient population, the company said. Based on the market-leading Valiant Captivia thoracic stent graft, the implant is outfitted with a branch cuff to accommodate the LSA's unique anatomy, allowing it to create a seal zone for endovascular repair without an invasive procedure.
"Thoracic aortic aneurysms involving branch vessels such as the LSA can be particularly challenging to treat," lead investigator Eric Roselli said in a statement. "The Valiant Mona LSA system could help address an unmet need in the treatment of thoracic aortic aneurysms. This is clearly reflected in the FDA's decision to help advance the development of this new therapy."
The early-stage promise sets the stage for further study of Mona LSA, and, by engaging the FDA from the get-go, Medtronic expects an accelerated regulatory process for the device.
Meanwhile, the world's largest devicemaker is still raking in revenue around the globe, boosting sales 2.4% last quarter to $4.2 billion thanks to growth in nearly all of its business units.
- read the statement