FDA approves Medtronic’s slimmer Valiant Navion thoracic stent graft

Medtronic HQ
Patients with smaller iliac arteries had previously been considered ineligible for thoracic endovascular aneurysm repair, the medtech giant said. (Medtronic)

Medtronic received FDA approval for its Valiant Navion thoracic stent graft for minimally invasive repair of all lesions of the descending thoracic aorta, a slimmer iteration that the company says allows for more patients to undergo a percutaneous procedure instead of open surgery.

The Navion system is a lower-profile version of Medtronic’s Valiant Captivia stent graft, and offers both covered and bare-metal proximal edge configurations for meeting varying patient anatomies and pathologies. It is designed to help treat thoracic aortic aneurysms, blunt thoracic aortic injuries, penetrating atherosclerotic ulcers, intramural hematomas and aortic type B dissections.

Patients with smaller iliac arteries had previously been considered ineligible for thoracic endovascular aneurysm repair, or needed additional procedures to address calcification or concerns over twists in the aorta.

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“A significant reduction of the delivery system profile enables physicians to better facilitate the endovascular treatment of patients with smaller, tortuous, and calcified access vessel arteries,” said Ali Azizzadeh, the U.S. principal investigator for Navion’s clinical study.

Its approval was based on an international study of 87 participants with thoracic aortic aneurysms, penetrating atherosclerotic ulcers and severe to life-threatening systemic disease, analyzing safety and efficacy after 30 days.

The Navion’s FreeFlo, or bare metal configuration, was implanted in 74.7% of procedures with no instances of access or deployment failures, while the CoveredSeal proximal configuration was implanted without issue in 25.3%. Through 30 days, peri-operative mortality rates stood at 2.3% with an equal rate of secondary procedures. Type Ia endoleaks were seen in one patient, or 1.2% at one-month imaging follow-up.