CSI Acquires Wirion Embolic Protection System From Gardia Medical

August 5, 2019—Cardiovascular Systems, Inc. (CSI) announced that it has acquired the Wirion embolic protection system and related assets from Gardia Medical Ltd., a wholly owned Israeli subsidiary of Allium Medical Solutions Ltd. The Wirion device is a distal embolic protection filter that is used to capture debris that can be associated with all types of peripheral vascular interventions.

CSI plans to commercialize the Wirion system in the United States after the transfer of manufacturing from Gardia Medical, which is expected to be completed after a 12- to 15-month transition period. Gardia will retain the rights to the Wirion system for angioplasty and stenting procedures in the carotid arteries, advised CSI.

According to CSI, Wirion received European CE Mark approval in June 2015 and FDA clearance in the United States in March 2018. Its use is indicated for containing and removing embolic material while performing angioplasty and stenting procedures in the carotid arteries and atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of the filter basket placement should be between 3.5 to 6.0 mm. Wirion may be used with commercially available 0.014-inch guidewires.

The company noted that the multicenter WISE-LE study conducted in the United States and Germany assessed the clinical performance of the Wirion embolic protection system in patients undergoing lower extremity atherectomy for the treatment of peripheral artery disease.

In October 2018, the results 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 study demonstrated a major adverse event rate of 1.9% with no clinically significant distal embolization when the Wirion system was used.