Medical device company Cardiovascular Systems Inc (CSI) (NASDAQ:CSII) revealed on Monday the completion of the acquisition of the WIRION Embolic Protection System and related assets from Gardia Medical Ltd, a wholly owned Israeli subsidiary of Allium Medical Solutions Ltd (TASE:ALMD), for an undisclosed amount.

The CE Mark and FDA approved WIRION Embolic Protection System device is a distal embolic protection filter used to capture debris that can be associated with all types of peripheral vascular intervention (PVI) procedures. Physicians use embolic protection devices in vessels located above the knee with long lesions, high plaque burden and poor run off. The WIRION System is easier to use and more versatile than other available embolic protection systems because it can be used with any .014" guidewire and for all types of peripheral interventions. In addition, the WIRION System is the only embolic protection device indicated for use with any atherectomy system.

Following the completion of transfer of manufacturing after the 12- to 15-month transition period, CSI intends to commercialise the WIRION System in the US as well as will retain the rights to the WIRION System for angioplasty and stenting procedures in the carotid arteries.

In conjunction, the WISE LE (WIRION EPS in Lower Extremities Arteries) was Gardia's multicenter study performed in the US and Germany and included all commercially-available atherectomy systems. The primary endpoint was freedom from major adverse events occurring within 30 days post-procedure that could result 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. The study included a histopathological analysis of debris captured by the filter.