Medtronic Launches AneuRx AAAdvantage Stent Graft On New Xcelerant Hydro Delivery System For Minimally Invasive Treatment Of Abdominal Aortic Aneurysm

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 11 Jan 2008 - 15:00 PDT

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Continuing its record of innovation in endovascular therapies for aortic aneurysms, Medtronic, Inc. (NYSE: MDT), announced the U.S. market launch of the AneuRx AAAdvantage(R) Stent Graft on the new Xcelerant(R) 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. In addition, Medtronic has also received approval from the U.S. Food and Drug Administration to introduce its latest generation of packaging materials for the launch of this product.

Present in an estimated 1.2 million people in the United States, 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 (EVAR). 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 post-operative complications and shorter recovery times than open surgical repair.

"The Xcelerant Hydro Delivery System is a significant innovation that will make endovascular repair using the AneuRx AAAdvantage Stent Graft a treatment option for more patients with abdominal aortic aneurysms," said Dr. Frank R. Arko, M.D., chief of Endovascular Surgery at the University of Texas Southwestern Medical Center in Dallas. "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 Xcelerant Hydro Delivery System will be used with the AneuRx AAAdvantage Stent Graft, which was introduced in the United States in March 2006. In bench testing, the Xcelerant Hydro Delivery System was shown to generate 68 times less friction than 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.

In addition, the Xcelerant Hydro Delivery System features a uniquely integrated sheath that is tapered on both ends. This dual-taper sheath is designed to facilitate insertion and retraction of the entire delivery catheter by minimizing the time that the surface area of the sheath is in contact with the artery wall. The integrated sheath also 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 Medtronic's Endovascular Innovations business. "Combined with the AneuRx AAAdvantage Stent Graft, Medtronic now offers U.S. endovascular physicians 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 100,000 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.

About Medtronic and the Medtronic Foundation

Medtronic, Inc. ( NYSE: MDT) headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world. The Medtronic Foundation is committed to improving the health of people and communities. Its grant making is focused in three areas: health, education and community.

Medtronic Foundation