This article is more than 5 years old. Information may no longer be current.
FDA approves new balloon-expandable stent to treat narrowed iliac arteries
Click Here to Manage Email Alerts
Medtronic today announced that the FDA has approved a balloon-expandable stent made from a cobalt-chromium alloy for the treatment of narrowed iliac arteries.
According to Medtronic, the Assurant Cobalt Iliac Balloon-Expandable Stent System is the first to receive approval to treat narrowed iliac arteries. The device complements the company’s self-expanding Complete SE Vascular Stent, which already has approval for an iliac indication.
The stent uses 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 conformability to the vessel wall without sacrificing radial strength. These features enable the stent to utilize a 6F 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, according to a press release.
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 press 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, of New York-Presbyterian Hospital and co-principal investigator for ACTIVE, stated in the press 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.”
 |
Follow CardiologyToday.com on Twitter. |