FDA Clears First Balloon-Expandable Stent for Iliac Arteries


November 4, 2011

November 4, 2011 — Medtronic Inc. announced approval by the U.S. Food and Drug Administration (FDA) of the Assurant Cobalt Iliac Balloon-Expandable Stent System.

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 the company’s self-expanding Complete SE Vascular Stent, 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.

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 United States sites.

The Assurant Cobalt stent 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 new stent leverages the strength of cobalt chromium and a unique modular design to create a device with ultrathin, round, edgeless struts. This allows for smooth delivery to iliac artery lesions and high conformability to the vessel wall without sacrificing radial strength.

It is the only balloon-expandable device to utilize a 6 French sheath for the entire size matrix — from the smallest (6 mm x 20 mm) to the largest (10 mm x 60 mm) size — for the treatment of iliac arteries.

For more information: www.medtronic.com