FDA has approved Medtronic’s low-profile thoracic endovascular aneurysm repair (TEVAR) endograft, Valiant Navion.
Medtronic designed the stent graft system to enable the minimally-invasive repair of lesions in the descending thoracic aortas of patients with small iliac arteries.
By expanding TEVAR to patients with a broader range of anatomies, Medtronic could gain an edge over its rivals for the market: Bolton Medical, Cook Medical and Gore Medical.
Over the past decade, TEVAR has established itself as the go-to approach for the treatment aortic aneurysms, blunt thoracic aortic injuries, aortic type B dissections and other conditions affecting the descending thoracic aorta. The move from open surgery to TEVAR is underpinned by evidence that the minimally-invasive approach results in better health outcomes.
Having ceded a headstart to TEVAR pioneer Gore, Medtronic has spent the past seven years working to claim a piece of the market. Those efforts centered on Valiant Captivia, which won FDA approval in 2011 and has been used in more than 100,000 procedures globally.
In parallel, Medtronic has developed a low-profile version of its first TEVAR device. The new device, Valiant Navion, is available in diameters of 20mm and up, and its delivery system features a tapered tip that is 10mm or more shorter than that found on the Captivia product. Medtronic also replaced the monofilament material used in Captivia with the same multifilament graft found in its Endurant line of aortic stent grafts.
The goal of the changes is to enable treatment of patients with small, calcified and tortuous access vessel arteries. Medtronic assessed whether it had achieved this goal in an 87-person clinical trial. Around one-third of the participants were women, who typically have smaller access vessels, and more than two-thirds had severe to life-threatening systemic disease.
There were no instances of access or deployment failures, the primary endpoint of the trial. In the 30 days following surgery, two patients died, two patients underwent secondary procedures and one patient suffered an endoleak due to a gap between the graft and vessel wall.
The results were strong enough for FDA to approve Valiant Navion for sale in the U.S. That done, Medtronic will now work to grow the sales of its TEVAR franchise by persuading physicians to use the Navion device.