Allium Medical has announced that it has received FDA clearance to market Gardia’s Wirion system in the United States for the carotid indication.
Asaf Alperovitz, CEO of Allium Group said: “Receiving FDA clearance to market the Wirion system in the US for the carotid clinical indication is a major achievement for Allium. […] The success in achieving all clinical endpoints [of the pivotal, multicentre trial], including the primary endpoint, based on half of the number of patients defined in the study protocol, while meeting stringent statistical criteria, is unprecedented for embolic protection devices. Meeting the clinical endpoints already at this early stage enabled us to streamline the process for obtaining FDA approval and to significantly shorten the timetable. “The Gardia Wirion system, which has been used successfully in over 350 procedures, in a variety of clinical indications, received a very favourable feedback from leading European physicians. The system includes significant competitive advantages over other FDA cleared embolic protection devices of world leading companies.”
About the system:
A press release from the company adds that the Wirion system is a unique, patent-protected embolic protection filter-type system that protects against blood clots and emboli produced during catheterisation procedures for opening blocked blood vessels. The system has a unique locking mechanism that allows the physician to use the any guide wire of choice and to place the filter in the most suitable and desired location. The flexibility to place the filter anywhere over any guide wire simplifies and streamlines the procedure, making it safer, convenient, and simple to use thus presenting significant advantages over other protection devices in the market. The Wirion system also includes a unique retrieval catheter for easy, quick and safe filter retrieval after stent deployment.
It is approved in the US for the clinical indication of emboli protection during carotid artery catheterisation procedures and in Israel (AMAR) and Europe (CE mark) for widespread use in all cardiovascular catheterisation procedures.