The FDA issued approval for Medtronic‘s Assurant cobalt-chromium balloon-expandable stent for treatment of narrowed iliac arteries in patients with peripheral vascular disease.
The new device’s 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. sites.
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 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.