FDA Approves Percutaneous Thoracic Stent Graft System

The US Food and Drug Administration (FDA) has approved a new thoracic stent graft system from Ireland-based medical device company Medtronic.

The Valiant Navion thoracic stent graft system, designed to repair all descending thoracic aorta lesions with minimal invasive care, has been granted approval for the US market. The Medtronic device is capable of repairing thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries (BTAI), penetrating atherosclerotic ulcers (PAU), intramural hematomas (IMH), and aortic type B dissections (TBAD).

The approval marks a commercial advancement in treatment availability for patients with small iliac arteries, who were previously ineligible for thoracic endovascular aneurysm repair (TEVAR), or required adjunctive procedures to address calcification and tortuosity concerns. The new device could allow for patients to receive care percutaneously.

The FDA has approved Valiant Navion on the results from a 30-day primary endpoint analysis involving 87 international patients with TAA and PAU. According to Medtronic, approximately 6 of every 100,000 people globally experience a TAA, which can lead to a life-threatening rupture and hemorrhage if left untreated. Patients were 37.9% female, and 71.3% suffered from a severe to life-threatening form of their systemic disease.

In the safety and efficacy assessment of the device, 50.6% of the procedures were performed percutaneously, with mean procedure and fluoroscopy times of 88.7 ± 53.4 minutes and 12.2 ± 8.8 minutes, respectively. At 30 days, patients reported a peri-operative mortality of 2.3%—only 2 patients had died from their disease, and another 2 required secondary procedures.

Ali Azizzadeh, MD, US principal investigator for the trial, noted that a significant reduction of the delivery system profile gives physicians the capability 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 investigational device exemption (IDE) subjects support this design,” Azizzadeh said.

The Valiant Navion system is a follow-up to the Valiant Captivia thoracic stent graft system from Medtronic which, by their count, has been involved in the treatment of 100,000-plus patients globally.

The focus of Medtronic remains on the advancement of complex aortic disease care, John Farquhar, vice president and general manager of the Aortic business, Cardiac and Vascular Group at Medtronic, said. A crux of that focus is on improving treatment outcomes and extending patient lives.

“This FDA approval now makes it possible for more patients with thoracic aortic disease to receive endovascular repair,” Farquhar said. “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.”