–– Oct. 31, 2011 –– Advancing the treatment of peripheral artery disease,
Medtronic, Inc. (NYSE: MDT) today announced approval by the U.S. Food and Drug
Administration (FDA) of the Assurant® Cobalt Iliac Balloon-Expandable Stent
The new medical device features the first balloon-expandable
stent made from a cobalt-chromium alloy to be approved by the FDA for the
treatment of narrowed iliac arteries. It complements Medtronics self-expanding
Complete® SE Vascular Stent, which is already approved with an iliac
indication. The iliac arteries branch off the aorta in the abdominal area and
carry blood to downstream vessels that perfuse the pelvis, legs and feet.
The new devices FDA approval was supported by the
nine-month results from the ACTIVE (Use of the Assurant Cobalt Iliac Stent
System in the Treatment of Iliac Vessel Disease) trial, which examined the
outcomes of 123 patients at 17 U.S.
The Assurant Cobalt stent demonstrated exceptional
technical, procedural and clinical success in the trial and had low rates
of major adverse events, target lesion revascularization (TLR) and target
vessel revascularization (TVR) –– all at 0.8 percent. In addition, the device
also achieved a 99.2 percent primary patency rate, meaning only one of the 123
study patients required a reintervention through nine months of follow-up.
“The Assurant Cobalt stent demonstrated excellent safety and
long-term patency in the prospectively conducted and core lab controlled ACTIVE
trial, with some of the lowest rates of 9-month TLR ever seen in an iliac
interventional trial,” said William A. Gray, M.D., of New York Presbyterian
Hospital and co-principal
investigator of ACTIVE. “The approval of this stent, along with the previous Complete
SE self-expanding stent, significantly adds to the armamentarium for interventionalists,
and therefore benefits our patients.”
The Assurant Cobalt stent leverages the strength of cobalt
chromium and a unique modular design to create a device with ultrathin, round,
edgeless struts, allowing for smooth delivery to iliac artery lesions and
excellent conformability to the vessel wall without sacrificing radial
strength. The combination of these design features enables the stent to be the
only balloon-expandable device to utilize a 6F sheath for the entire size
matrix –– from the smallest (6mm x 20mm) to the largest (10mm x 60mm) size ––
for the treatment of iliac arteries.
In collaboration with leading clinicians, researchers and
scientists worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias.
Medtronic, Inc. (www.medtronic.com),
headquartered in Minneapolis,
is the global leader in medical technology – alleviating pain, restoring health
and extending life for millions of people around the world.