Cardiovascular Systems recently announced that it has acquired the Wirion embolic protection system and related assets from Gardia Medical.
The device, which received CE Mark in June 2015 and US Food and Drug Administration (FDA) clearance in March 2018, is a distal embolic protection filter used to capture debris that can be associated with all types of peripheral vascular intervention (PVI) procedures. Physicians typically use embolic protection devices in vessels located above the knee with long lesions, high plaque burden and poor run off.
Ehrin Armstrong, professor of Medicine at the University of Colorado (Boulder, USA), said, “The use of an embolic protection device during peripheral interventions where the risk of embolisation is higher provides assurance and protection from procedural complications.”
The Wirion system is easier to use and more versatile than other available embolic protection systems because it can be used with any 0.014” 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. The WISE LE study also demonstrated a major adverse event (MAE) rate of 1.9%, which is lower than any other previously reported rates with other embolic filters. Importantly, no clinically significant distal embolisation was observed when the Wirion System was used.
Asaf Alperovitz, chief executive officer of Allium Medical Solutions, said, “Allium Medical’s mission is to develop innovative products to improve outcomes for patients around the world. We believe the Wirion system from Gardia Medical, one of our portfolio companies, will be highly synergistic with Cardiovascular System’s growing portfolio of products. We will continue to partner with the company to execute a timely manufacturing transfer and get the product in the hands of physicians.”
Scott Ward, Cardiovascular Systems chairman, president and chief executive officer, said, “The acquisition of the Wirion system further supports our commitment and mission of building a comprehensive portfolio of differentiated products aimed at saving limbs and improving outcomes for patients undergoing complex peripheral interventions.”
Cardiovascular Systems plans to commercialise the Wirion system in the USA following the transfer of manufacturing from Gardia Medical. The company expects the manufacturing transfer 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.