Medtronic (Minneapolis) reported the U.S. market launch of the Talent thoracic stent graft on the Xcelerant delivery system, which the company says makes minimally invasive treatment of thoracic aortic aneurysms easier to perform.
The Talent system is designed to provide a minimally invasive alternative to open surgery for patient's with life-threatening aneurysms in the upper portion of the aorta, the body's largest artery. Thoracic endovascular aortic repair (TEVAR) is a procedure in which a stent graft is threaded through the femoral artery and expanded at the site of the aneurysm, Medtronic said. Once in place, the stent graft creates a new path for blood flow, reducing pressure on the aneurysm and the risk of rupture. Left untreated, aortic aneurysms can burst, an emergency situation that commonly results in death due to extensive internal bleeding, the company noted.
Tony Semedo, VP and general manager of Endovascular Innovations, part of the CardioVascular business at Medtronic, told Medical Device Daily that the wide diameter range — from 22 mm to 46 mm — of the Talent graft makes the device unique compared to competing devices because it makes TEVAR procedures available to an additional 25% of patients.
FDA approved the Talent stent graft in June (Medical Device Daily, June 6, 2008) for certain aneurysms of the descending thoracic aorta, but it has been available outside the U.S. since the late 1990s. The device is safe and effective compared to open surgery, according to research published by the Society for Vascular Surgery (SVS; Chicago) in last month's Journal of Vascular Surgery.
Semedo also noted that the stent graft features a five-peak, bare-metal spring on the proximal end so it can be placed higher in the thoracic area without occluding blood flow through the carotid arteries, which feed the brain.
As for the Xcelerant delivery system, Semedo said it has a "twist-and-release" design which "allows us to deploy the stent graft from the top, or proximal end, of the of the stent graft down" for a more controlled deployment compared to the more traditional method of deploying the stent graft from the middle to the ends. He also touted the improved trackability of the new deployment system, which he said makes it easier for the physician to gain access to and navigate the aortic arch and tight iliac arteries.
"With the availability of the Xcelerant system, it basically is going to help to make the procedures easier for the physician, in particular in patients who have challenging anatomies, Semedo said.
Once in place, Medtronic said that the Talent graft's longitudinal support bar gives it strength but also maintains device flexibility to accommodate highly angulated and eccentrically shaped thoracic aortas.
According to Medtronic, the unique features of the Xcelerant delivery system and the Talent graft provide "meaningful benefits to both physician and patient: a wide range of sizes so more patients can be treated; improved trackability and controlled deployment for easier and more accurate stent graft placement; and high radial force as shown in competitive bench testing."
Semedo said the Xcelerant delivery system "unlocks the full potential" of the Thoracic stent graft by "combining unique features that are unavailable in the current alternatives."
Karthikeshwar Kasirajan, MD, a vascular surgeon and professor at Emory University Hospital (Atlanta), is among the first U.S. physicians to have implanted a Talent graft using the Xcelerant delivery system. "This combination of a proven stent graft and an advanced delivery system marks a major step forward for the minimally invasive treatment of thoracic aortic aneurysms," Kasirajan said. "The system facilitates stent graft delivery and deployment with greater ease and control, especially through narrow vessels and challenging anatomies."
Ronald Fairman, MD, professor and chief of the division of vascular surgery and endovascular therapy at the Hospital of the University of Pennsylvania (Philadelphia), served as the principal investigator of the clinical study that supported FDA approval of the Talent graft. "Given the wide diameter treatment range, 25% of implanted subjects in the VALOR trial could not have been treated with current commercially available devices," he said.
Medtronic's portfolio of aortic stent grafts includes the Talent abdominal and thoracic stent graft systems worldwide; the AneuRx AAAdvantage abdominal stent graft system in the U.S.; and the Endurant abdominal and Valiant thoracic stent graft systems outside the U.S.