WISE Evaluates Wirion Embolic Protection System in Patients Undergoing CAS
April 12, 2017—Findings from the pivotal WISE study were published online ahead of print by Dierk Scheinert, MD, et al in Circulation: Cardiovascular Interventions. WISE evaluated the safety and performance of Allium Medical's Wirion embolic protection system (EPS) in patients undergoing carotid artery stenting (CAS). The Wirion device is used to deploy an independent distal filter using any 0.014-inch guidewire. The investigators concluded that the data suggest that the use of an independent modular filter for CAS in high-surgical-risk patients is safe and effective.
As summarized in Circulation: Cardiovascular Interventions, the prospective, multicenter, nonrandomized, open-label, single-arm study of CAS in high-surgical-risk patients was performed. The primary endpoint (a composite of death, stroke, and myocardial infarction at 30 days) was compared with performance goals derived from historical controls. Secondary endpoints were components of the primary endpoint and the device, angiographic, procedural, and clinical success rates. Preplanned interim analysis was conducted on the first 120 patients.
The investigators reported that at interim analysis, the primary endpoint was significantly lower for the Wirion EPS group, compared with historical data (3.3% vs 6.3%; P = .0008). Analysis of primary endpoint components in the WISE group, compared with the historical control group, shows numerically lower mortality (0% vs 1.7%; P = .21), stroke (2.5% vs 4.6%; P = .18), and myocardial infarction (0.8% vs 1.5%; P = .5). Device, angiographic, procedural, and clinical success was achieved in 99.2%, 99.1%, 98.3%, and 96.6% of cases, respectively.
The outcomes suggest that use of an independent modular filter may be associated with a lower rate of embolic complications associated with carotid stent placement, advised the investigators in Circulation: Cardiovascular Interventions.
In June 2015, Allium Medical, an Israeli medical device company, announced that it received US Food and Drug Administration clearance to market the Gardia Wirion system in the United States for the clinical indication of emboli protection during carotid artery catheterization procedures. In Israel and Europe, it is approved for widespread use in all cardiovascular catheterization procedures.