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Balloon-Expandable Stent Gains FDA Approval for Use in Narrowed Iliac Arteries
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The FDA has approved a balloon-expandable stent for the treatment of narrowed iliac arteries, the first ever to be made from a cobalt-chromium alloy and approved for this indication, according to the manufacturer.
The stent (Assurant Cobalt Iliac, Medtronic) uses cobalt chromium and a modular design to create a device with ultrathin, round, edgeless struts, allowing for smooth delivery to iliac artery lesions and conformability to the vessel wall without sacrificing radial strength, a press release stated. These features enable the stent to utilize a 6F sheath for the entire size matrix — from the smallest (6 mm ×20 mm) to the largest (10 mm × 60 mm) size — for the treatment of iliac arteries.
Approval was supported by 9-month data from the ACTIVE trial, which studied outcomes in 123 participants at 17 US sites. The stent demonstrated technical, procedural and clinical success in the trial and was associated with low rates of major adverse events, target lesion revascularization and target vessel revascularization (0.8% for all). The device also achieved a 99.2% primary patency rate; only one of the 123 participants required a reintervention during the 9-month follow-up, according to information from the release.
“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,” William A. Gray, MD, director of endovascular services at Columbia University Medical Center/New York-Presbyterian Hospital, New York, and co-principal investigator for ACTIVE, stated in the release. “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.”
Disclosure: Dr. Gray reports receiving minor compensation as a consultant for Medtronic.