Results Published From Pivotal WISE-LE Trial of Gardia Medical's Wirion EPS in Lower Extremity Atherectomy
October 4, 2018—Results of the pivotal WISE-LE trial evaluating the Wirion embolic protection system (EPS; Gardia Medical) were published by Nicolas W. Shammas, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2018;11:1995–2003). The Primary Investigator of the WISE-LE study is Bill Gray, MD, who is with Lankenau Heart Institute in Philadelphia, Pennsylvania.
The multicenter study, which was conducted in the United States and Germany, was designed to assess the clinical performance of the Wirion EPS in patients undergoing lower extremity atherectomy for the treatment of peripheral artery disease.
As summarized in JACC: Cardiovascular Interventions, the primary endpoint was freedom from major adverse events (MAEs) occurring within 30 days postprocedure and was compared with an objective performance goal derived from historical atherectomy trials. MAE was defined as a serious adverse event that resulted in death, acute myocardial infarction, thrombosis, pseudoaneurysm, dissection (≥ grade C), or clinical perforation at the filter location, clinically relevant distal embolism, unplanned amputation, or clinically driven target vessel revascularization.
The study also included a histopathological analysis of debris captured by the filter during the procedures.
The investigators reported that the study protocol specified enrollment of 153 patients with the primary endpoint successfully met if ≤ 18 (12%) MAEs occurred. A prespecified interim analysis performed after 103 patients revealed only two MAEs, and the study was stopped because it had met its predetermined metric for success.
A lesion deemed not accessible by the Wirion EPS occurred in seven patients. Debris that were < 1 mm, 1 to 2 mm, and > 2 mm in diameter were found in 98%, 22%, and 9% of patients, respectively.
The Wirion EPS is safe and noninferior to the prespecified performance goal in capturing debris in the vast majority of patients and with the use of a broad range of atherectomy systems, concluded the WISE-LE study investigators in JACC: Cardiovascular Interventions.
In September 2017, Gardia Medical announced that the clinical results from the WISE-LE study, which was conducted under an FDA investigational device exemption, would support an anticipated application for 510(K) clearance to market the Wirion EPS in the United States with a label that covers use with all atherectomy devices (ie, orbital, rotational, directional, laser) in lower extremity atherectomy.
The Wirion device is currently cleared by the FDA for use during carotid artery stenting. It is also approved for marketing in Australia for the carotid indication. In Europe and Israel, it is approved for use for all cardiovascular indications.
The Wirion EPS is indicated to provide protection from blood clots and emboli that occur during catheterization. The system's locking mechanism allows the physician to use any guidewire throughout the procedure and to place the filter in any location on the guidewire. The Wirion system's catheter allows for retrieval of the filter following the placement of the stent.