This article is more than 5 years old. Information may no longer be current.
FDA grants premarket approval to thoracic endovascular graft
Click Here to Manage Email Alerts
The FDA has issued premarket approval to Cook Medical for a thoracic endovascular graft system for the treatment of isolate lesions in the descending thoracic aorta in patients eligible for endovascular repair, according to a press release.
Approval of the Zenith Alpha Thoracic device follows results of two pivotal trials that indicated safety and efficacy of the device among patients with aortic aneurysm or ulcer and blunt traumatic injury, according to the release.
The device features a low-profile introduction system that requires few steps for deployment, and is intended to improve conformability in tortuous anatomy and avoid potential access issues caused by larger-profile systems during thoracic endovascular aortic repair, according to the release.
“Despite all the successes we’ve seen over the past few decades in endovascular aneurysm repair, we continue to be frustrated when we have to put a large sheath through iliac arteries that are smaller than the delivery system,” Karl Illig, MD, professor of surgery and director of the vascular surgery division at University of South Florida Morsani College of Medicine in Tampa, said in the release. “Development, testing and now approval of the Zenith Alpha Thoracic device is long-awaited in this regard.”
The device received a CE Mark in 2013 for use in Europe.
Disclosure: Illig is a paid global principal investigator for the clinical trial of the device.