FDA Expands Indications for Medtronic Aortic StentFDA Expands Indications for Medtronic Aortic Stent

Medtronic Inc. recently announced that its Valiant thoracic stent graft, along with its Captivia delivery system, has received FDA approval for treating dangerous tears in the upper segment of the body's main artery. The approval, announced Tuesday, is specifically for treating type B aortic dissections. The Valiant device had originally been approved for complex isolated lesions of the descending thoracic aorta in October 2012, but dissections were specifically excluded. The original FDA Approval Letter says, "Some of the complex isolated lesions include aneurysms, transections, penetrating ulcers, and abnormal collections of blood within the aortic wall (intramural hematomas)." The new expanded approval removes the exclusion of dissections. Medtronic says type B aortic dissections are "a serious cardiovascular condition associated with high morbidity and mortality in which the upper segment of the body's main artery has become torn along the innermost layer of the vessel wall."

The Medtronic device was approved following the successful completion of the U.S. Medtronic Dissection trial. Results of this trial were presented January 27 at the annual meeting of the Society of Thoracic Surgeons in Orlando, FL, by Joseph Bavaria, MD, professor of surgery and director of the thoracic aortic surgery program at the University of Pennsylvania in Philadelphia, and a national principal investigator for the Dissection trial."The trial we conducted shows that endovascular repair with the Valiant Captivia System provides a safe, effective, and potentially life-saving treatment option for acute dissection patients," says Bavaria. According to the Medtronic press release, "12-month data from the 50 patients evaluated in Dissection demonstrate safety and efficacy of the Valiant Captivia System in the treatment of dissections, with excellent technical success." The trial was conducted at 16 U.S. sites and, Medtronic says, achieved 100% technical success and 100% coverage of the primary entry tear at implant.Rodney White, MD, chief of vascular surgery at Harbor-UCLA Medical Center (Torrance, CA), and the trial's leading enroller, added, "Data out to one year continue to show positive aortic remodeling of the stented segment, with a 100% increase in true lumen volume and no ruptures." The Valiant stent system is the second such device to receive FDA approval for this indication. W.L. Gore & Associates Inc.'s TAG thoracic endoprosthesis received approval in September.