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Thoracic stent graft system received FDA approval
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Medtronic announced that a thoracic stent graft system for the treatment of patients with lesions of the descending thoracic aorta has received approval from the FDA.
The thoracic stent graft system (Valiant Navion, Medtronic) is used to repair lesions in a minimally invasive manner including blunt thoracic aortic injuries, thoracic aortic aneurysms, intramural hematomas, penetrating atherosclerotic ulcers and aortic type B dissections, according to a press release from the company.
This system is a lower-profile version of another thoracic stent graft system (Valiant Captivia, Medtronic) and features two stent configurations (CoveredSeal and FreeFlo, Medtronic), allowing physicians to adapt the system to various patients’ pathologies and anatomies, according to the release.
“A significant reduction of the delivery system profile enables physicians to better facilitate the endovascular treatment of patients smaller, tortuous and calcified access vessel arteries,” Ali Azizzadeh, MD, director of the division of vascular surgery, vice chair of the department of surgery for programmatic development and associate director of the Heart Institute for Vascular Therapeutics at Cedars-Sinai Medical Center, said in the press release. “Furthermore, the challenging anatomical and comorbid baseline characteristics and resulting clinical evidence of the global investigational device exemption [IDE] subjects support this design.”
Patients with small iliac arteries were previously considered ineligible for thoracic endovascular aneurysm repair or procedures required to accommodate tortuosity and calcification concerns. The system allows more patients to undergo a percutaneous procedure, according to the release.
The FDA approval was based on an IDE study with 87 patients with thoracic aortic aneurysm and penetrating atherosclerotic ulcers. Patients were implanted with either the FreeFlo (74.7%) or the CoveredSeal configuration (25.3%), a percutaneous access approach was used 50.6% of the time and there were no instances of access or deployment failures at implant. During 30 days of follow-up, there were low rates of secondary procedures (2.3%) and perioperative mortality (2.3%), while type Ia endoleaks occurred in 1.2% of patients, the company stated in the release.
“This FDA approval now makes it possible for more patients with thoracic aortic disease to receive endovascular repair,” John Farquhar, vice president and general manager of the aortic business of the cardiac and vascular group at Medtronic, said in the release.
Disclosure: Azizzadeh is a principal investigator of the Valiant Navion IDE study and reports he received research funding and honoraria from and consults for Medtronic and W.L. Gore and Associates. Farquhar is an employee of Medtronic.