Allium Medical Announces FDA Clearance of Carotid Indication for the Gardia Wirion Embolic Protection Device

June 7, 2015—Allium Medical, an Israeli medical device company specializing in minimally invasive technologies, announced that it received US Food and Drug Administration clearance to market the Gardia Wirion system for a carotid indication in the United States. The approval follows the device’s success in meeting all clinical endpoints at the early stage of recruiting half the patients (120 patients out of a full cohort of 240) in a clinical study of the device, noted the company. 

The Wirion system is now approved for marketing in the United States for the clinical indication of emboli protection during carotid artery catheterization procedures. In Israel and Europe, it is approved for widespread use in all cardiovascular catheterization procedures. 

According to the company, the Wirion embolic protection filter-type system protects against blood clots and emboli produced during catheterization procedures. The system has a unique locking mechanism that allows the physician to use any guidewire and to place the filter in the most suitable and desired location. The flexibility to place the filter anywhere over any guidewire simplifies and streamlines the procedure, making it safe, convenient, and simple to use. The Wirion system also includes a retrieval catheter for easy, quick, and safe filter retrieval after stent deployment, stated Allium.