Cardiovascular Systems has announced that the first patients in the USA have been treated with the Wirion embolic protection system. Wirion is a distal embolic protection filter used to capture thrombus and debris that can be associated with all types of peripheral vascular intervention procedures, including atherectomy.
Lawrence Garcia, St Elizabeth’s Medical Center, Boston, USA and Nicolas Shammas, Unity Point Health-Trinity Bettendorf, Davenport, USA participated in the WISE LE study where Wirion demonstrated a major adverse event (MAE) rate of 1.9%, which is lower than previously reported rates for other lower extremity embolic protection filters. Importantly, no clinically significant distal embolization was observed when Wirion was used.
Garcia commented: “Wirion represents a critical advancement for distal embolic protection devices. With Wirion, I can use my preferred 0.014” 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.”
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.”
Scott R Ward, CSI Chairman, president and chief executive officer, said: “We are excited to announce the commercialisation of Wirion. This product will be an important part of our comprehensive portfolio of differentiated products designed to save limbs and improve outcomes for patients undergoing complex peripheral interventions.”