Medtronic (NYSE:MDT) said today that it won FDA approval for its Valiant Navion thoracic stent graft system intended for use in the minimally invasive repair of lesions in the descending thoracic aorta.
The Fridley, Minn.-based company said that the stent system is now cleared for use in procedures to repair thoracic aortic aneurysms, blunt thoracic aortic injuries, penetrating atherosclerotic ulcers, intramural hematomas and aortic type B dissections.
Medtronic said that the newly cleared Valiant Navion stent will enable patients with small iliac arteries to undergo thoracic endovascular aneurysm repairs, and will open percutaneous procedures to patients who had previously been limited from them due to anatomical concerns.
“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,” aortic biz GM John Farquhar said in a prepared statement.
The Valiant Navion is a low-profile version of the company’s Valiant Captivia thoracic stent system, and features both CoveredSeal and FreeFlo stent configurations.
Approval for the stent system came based on 30-day primary endpoint analysis of 87 subjects in an international investigational device exemption study which explored the safety and efficacy of the Valiant Navion for patients with thoracic aortic aneurysms and penetrating atherosclerotic ulcers.
Results from the trial indicated that stents in the FreeFlo configuration, which were used in 74.7 of procedures, and those in the CoveredSeal version, used in 25.3% of cases, both showed no instances of access or deployment failures. The majority of procedures in the trial were performed through a percutaneous access approach with mean procedure and fluoroscopy times of 88.7 ± 53.4 minutes and 12.2 ± 8.8 minutes, respectively.
Data indicated a 2.3% rate of peri-operative mortality and 2.3% rate of secondary procedures at 30 days, with a 1.2% rate of Type 1a endoleaks.
“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 investigational device exemption subjects support this design,” Valiant Navion IDE study principal investigator Dr. Ali Azizzadeh said in a press release.
Earlier this month, Medtronic said that it launched its Control Workflow system in the U.S. for use with its SynchroMed II intrathecal drug-delivery system.