Continuing its record of innovation in endovascular therapies for aortic aneurysms, Medtronic, Inc. (NYSE: MDT), today announced the European market launch of the Talent™ Abdominal Stent Graft on the new Xcelerant® Hydro Delivery System, which features a hydrophilic coating designed to aid navigation of the device through tight and tortuous arteries by reducing friction with the artery wall.
"The Xcelerant Hydro Delivery System is a significant innovation that will make endovascular repair (EVAR) using the Talent Stent Graft a treatment option for more patients with abdominal aortic aneurysms," said Dr. Dierk Scheinert, MD, PhD, of Park-Hospital and University of Leipzig - Heartcenter in Germany, and the leader of the first team worldwide to implant the device using the new delivery system. "It will simplify the procedure for endovascular interventionalists in treating patients whose iliac arteries are difficult to navigate when they are small and tortuous." The iliac arteries connect the femoral arteries, the entry point for stent grafts, to the aorta, the site of aortic aneurysms.
The Xcelerant Hydro Delivery System represents the seventh generation of innovation for the Talent Abdominal Stent Graft, which was introduced in Europe in April 1998. In bench testing, the Xcelerant Hydro Delivery System was shown to generate a 99 percent reduction in friction compared to the previous delivery system, which does not have the hydrophilic coating. Hydrophilic means "affinity for water"; because water is a major component of blood, the hydrophilic coating is designed to ease the delivery system's passage through the artery.
The Xcelerant Hydro Delivery System features a uniquely integrated sheath that contributes to the system's low profile characteristics, which are intended to enable excellent tracking and access through small vessels.
"Experience remains the foundation of our innovations in endovascular therapy, and the Xcelerant Hydro Delivery System represents our latest innovative contribution to this exciting field," said Katie Szyman, vice president and general manager of the Endovascular Innovations business at Medtronic. "Combined with the Talent Stent Graft, Medtronic now offers endovascular physicians in Europe an even stronger option for their EVAR procedures."
Medtronic has been an innovator and leader in the endovascular stent graft industry for more than a decade, as evidenced by more implants than any other company. Its long history includes more than 130,000 patients treated with aortic stent grafts dating back to 1995. Medtronic currently offers the broadest portfolio of endovascular stent grafts in the industry. These include the AneuRx AAAdvantage Abdominal Stent Graft System in the United States, and the Talent Abdominal, Talent Thoracic and Valiant Thoracic Stent Graft Systems outside the United States.
Present in an estimated one million people in Europe, an abdominal aortic aneurysm (AAA) is a dangerous bulge or weakening of the body's main artery that can rupture with fatal consequences if left untreated. If detected before rupturing, AAAs with diameters of more than twice the size of the normal infrarenal aorta are typically treated with either open surgical repair or endovascular repair. In contrast to open surgical repair, EVAR involves a minimally invasive procedure in which a tube-like sleeve called a stent graft is threaded through the femoral artery in a compressed state on a delivery system and expanded inside the aorta at the site of the aneurysm. Once in place, the sleeve creates a new path for blood flow, reducing pressure on the aneurysm. The delivery system is then removed.
EVAR has been shown to be an effective therapy for AAA, with fewer postoperative complications and shorter recovery times than open surgical repair. In a landmark study conducted in the United Kingdom and published in The Lancet (Sept. 4, 2004), the 30-day mortality rate for EVAR patients was 1.7 percent compared to 4.7 percent for patients who underwent open repair - a nearly threefold difference. Similarly, results from a U.S. study published recently in The New England Journal of Medicine (Jan. 31, 2008) indicate that perioperative mortality was significantly lower after EVAR than after open repair (1.2 percent vs. 4.8 percent - a fourfold difference).
No comments:
Post a Comment