Medtronic has just received approval from the FDA to market its Talent™ Thoracic Stent Graft System for minimally invasive treatment of aneurysms of the descending thoracic aorta. We’ve been following the Medtronic’s Talent line of endoaortic grafts for some time now (see flashbacks below).
The Talent Thoracic Stent Graft System makes thoracic endovascular aortic repair (TEVAR) accessible to an additional 25 percent of patients, because of its unique features. It is available in the widest range of diameters – from 22 mm to 46 mm. This size matrix offers physicians multiple options to customize devices for their patients’ needs and to treat a wider range of anatomies than with the other available endografts.
The Medtronic-sponsored Investigational Device Exemption (IDE) study of the Talent Thoracic Stent Graft System is called the VALOR clinical trial and enrolled 195 subjects at 38 medical centers between December 2003 and June 2005. All 195 patients received a Talent Thoracic Stent Graft, and their outcomes were compared to 189 open surgical control patients at three centers of excellence who matched selected inclusion/exclusion criteria of the VALOR trial. Dr. Fairman served as VALOR’s principal investigator.
The Talent Thoracic Stent Graft System Test Group met its primary safety and efficacy endpoints, with an all-cause mortality of 16.1 percent and a successful aneurysm treatment rate of 89.2 percent at 12 months. In the VALOR trial, 30-day mortality was 2.1 percent and aneurysm-related mortality at 12 months was 3.1 percent. The VALOR data show that endovascular therapy with the Talent Thoracic Stent Graft results in lower mortality than open surgery, as well as low rates of morbidity and device-related adverse events.
In mid-April, Medtronic received FDA approval for the Talent Abdominal Stent Graft for endovascular aortic repair (EVAR) of abdominal aortic aneurysms. Both the Talent Abdominal and Thoracic devices represent new options for many U.S. patients with aortic disease that would otherwise require open surgery.
Press release: Medtronic Receives FDA Approval for Talent™ Thoracic Stent Graft as Minimally-Invasive Treatment for Aortic Disease …
Flashbacks: Talent™ Thoracic Stent Graft System ; FDA OK’s Endovascular Talent Stent for AAAs; Endovascular Talent™ for AAAs