The US Food and Drug Administration (FDA) has approved Medtronic's Valiant Navion thoracic stent graft system, making it possible for more patients with thoracic aortic disease to receive endovascular repair.
Image: Medtronic secures FDA approval for new thoracic stent system. Photo: Courtesy of Medtronic.
The Valiant Navion system has been approved for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries (BTAI), penetrating atherosclerotic ulcers (PAU), intramural hematomas (IMH), and aortic type B dissections (TBAD).
Medtronic said until now, patients with small iliac arteries were considered ineligible for thoracic endovascular aneurysm repair (TEVAR) or required adjunctive procedures to accommodate calcification and tortuosity concerns.
The Valiant Navion system enables more patients to percutaneous procedure and overcome anatomical concerns and offers a less invasive approach of treatment compared to surgical cut-down procedures.
The lower-profile evolution of Valiant Captivia thoracic stent graft system is claimed to have been used in more than 100,000 patients globally.
Valiant Navion is built on the design philosophy of the Valiant Captivia system for enhanced performance and increased patient applicability.
The system includes CoveredSeal (proximal covered) and FreeFlo (proximal bare metal) stent configurations, offering physicians with two graft options for treating varying patient anatomies and pathologies.
Medtronic cardiac and vascular group, aortic business vice president and general manager John Farquhar said: “Our focus at Medtronic continues to be on advancing the treatment of complex aortic disease to improve outcomes and extend life.
“This FDA approval now makes it possible for more patients with thoracic aortic disease to receive endovascular repair. This therapy is truly a testament to our more than 20 years of clinical and engineering insights, and we look forward to making it available to those in need.”
The company stated that the FDA had given its approval after a 30-day primary endpoint analysis of 87 subjects consecutively enrolled in the international, multicenter, prospective investigational device exemption (IDE) study analyzing the safety and efficacy of Valiant Navion in subjects with thoracic aortic aneurysm (TAA) and Penetrating atherosclerotic aortic ulcer (PAU).
The study included real-world patient population with 37.9% female enrollment and 71.3% subjects with severe to life-threatening systemic disease (ASA physical status classification III/IV).
Results from the study showed low rates of peri-operative mortality at 2.3% (2/87) and secondary procedures at 2.3% (2/87). The rate of Type Ia endoleaks was 1.2% (1/87) with imaging follow-up, after one-month.