First Patients Treated With CSI’s Wirion System for Lower Extremity Embolic Protection

March 17, 2021—Cardiovascular Systems, Inc. (CSI) announced that the first patients in the United States have been treated with the company’s Wirion embolic protection system (EPS). The Wirion EPS has received FDA clearance and CE Mark approval.

According to the company, the Wirion distal embolic protection filter is used to capture thrombus and debris that can be associated with all types of peripheral vascular intervention procedures, including atherectomy. Wirion is indicated for use as an EPS to contain and remove embolic material (thrombus/debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5 to 6 mm. Wirion may be used with commercially available 0.014-inch guidewires, advised the company.

In August 2019, CSI acquired the Wirion device and related assets from Gardia Medical Ltd., a wholly owned Israeli subsidiary of Allium Medical Solutions Ltd.

Wirion EPS was evaluated in lower extremity arteries in the WISE LE pivotal trial. In October 2018, results of WISE-LE were published by Nicolas W. Shammas, MD, et al in Journal of the American College of Cardiology: Cardiovascular Interventions (2018;11:1995-2003). The Primary Investigator of the WISE-LE study was Bill Gray, MD, with Lankenau Heart Institute in Philadelphia, Pennsylvania.

The company stated that the WISE LE multicenter study was conducted in the United States and Germany and included all commercially available atherectomy systems. The primary endpoint was freedom from major adverse events occurring within 30 days postprocedure and was compared with an objective performance goal derived from historical atherectomy trials. Major adverse events were defined as a serious adverse event that resulted in death, acute myocardial infarction, thrombosis, pseudoaneurysm, dissection (grade C or greater), or clinical perforation at the filter location, clinically relevant distal embolism, unplanned amputation, or clinically driven target vessel revascularization.

Wirion demonstrated a major adverse event rate of 1.9%, which is lower than previously reported rates for other lower extremity embolic protection filters. Additionally, no clinically significant distal embolization was observed when Wirion was used.

Lawrence Garcia, MD, from St. Elizabeth’s Medical Center in Boston, Massachusetts, and Dr. Shammas from Unity Point Health-Trinity Bettendorf in Davenport, Iowa, participated as investigators in the WISE LE study.

“Wirion represents a critical advancement for distal embolic protection device,” commented Dr Garcia in CSI’s press release. “With Wirion, I can use my preferred 0.014-inch guidewire to cross the lesion and then place the filter anywhere on the wire. As a result, I am able to provide extensive support, individualized to each patient and intervention.”

Dr. Shammas added, “Delivery and retrieval of Wirion are easy with a minimal learning curve. Debris capture is very efficient, making Wirion exceptionally suited for use with any atherectomy device.”