October 22, 2018
FDA Approves Medtronic's Valiant Navion Thoracic Stent Graft System
October 23, 2018—Medtronic announced that it has received FDA approval for its Valiant Navion thoracic stent graft system for thoracic endovascular aneurysm repair (TEVAR) of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAAs), blunt thoracic aortic injuries, penetrating atherosclerotic ulcers (PAUs), intramural hematomas, and type B aortic dissections.
According to Medtronic, the Valiant Navion system is a lower-profile evolution of the company's Valiant Captivia thoracic stent graft system and allows for TEVAR treatment of patients with small iliac arteries. The Valiant Navion system also features the company's CoveredSeal proximal covered stent and FreeFlo proximal bare-metal stent configurations, providing two graft options to treat various patient anatomies and pathologies.
Approval was based on 30-day primary endpoint analysis of 87 patients consecutively enrolled in the international, multicenter, prospective investigational device exemption (IDE) study analyzing the safety and efficacy of Valiant Navion in patients with TAA and PAU. The study included a challenging real-world patient population with 37.9% female enrollment and 71.3% patients with severe to life-threatening systemic disease (American Society of Anesthesiologists physical status classification III/IV).
Medtronic reported that efficacy was demonstrated with the following results:
- The FreeFlo configuration was implanted in 74.7% of procedures with no instances of access or deployment failures at implant in the full study cohort.
- The new CoveredSeal proximal configuration was implanted in 25.3% of procedures with no instances of access or deployment failures at implant in the full study cohort.
- The majority of procedures (50.6%) were performed through a percutaneous access approach, leading to operational efficiency with mean procedure and fluoroscopy times of 88.7 ± 53.4 minutes and 12.2 ± 8.8 minutes, respectively.
- Through 30 days, there were low rates of perioperative mortality at 2.3% (2/87) and secondary procedures at 2.3% (2/87).
- At 1-month imaging follow-up, the rate of type Ia endoleaks was 1.2% (1/87).
Ali Azizzadeh, MD, served as the United States Principal Investigator for the Valiant Navion IDE study. In Medtronic's announcement, Dr. Azizzadeh commented, "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. Furthermore, the challenging anatomical and comorbid baseline characteristics and resulting clinical evidence of the global IDE subjects support this design."