50° CLEAR, FDA OK's Medtronic abdominal stent
Last Modified: Wednesday, April 16, 2008 at 11:51 a.m.
Medtronic Inc., which develops vascular technology in Santa Rosa, said Wednesday that U.S. drug regulators have approved its new device for treating abdominal aortic aneurysms, which kill 15,000 people in the United States each year.
The Talent Abdominal Stent Graft on the CoilTrac Delivery System is designed for 20 percent of patients who can’t be treated with existing stent graft systems, Medtronic officials said.
The stent graft was developed in Santa Rosa and is made at a Medtronic facility in Tijuana, Mexico. It is loaded on the delivery system and packaged in Santa Rosa, said Medtronic spokesman Joe McGrath.
The Talent device has been available in Europe for several years. The U.S. Food and Drug Administration approved it for the U.S. market on Tuesday.
An abdominal aortic aneurysm is a bulge or weakening of the body’s main artery that can rupture, causing internal bleeding and death.
Stent grafts are tiny metal-and-fabric devices that are delivered through an artery and placed at the site of the aneurysm. They create a new path for blood to flow, reducing pressure on the aneurysm.
Medtronic has about 1,200 employees in Santa Rosa.
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