CAESAREA, Israel, June 8, 2015 /PRNewswire/ --
Allium Medical (TASE: ALMD), an Israeli medical device company specializing in minimally invasive technologies announced today that it received FDA clearance to market Gardia’s WIRION system in the US for the carotid indication. The FDA clearance was received in accordance with the timetable the company announced. The approval follows the unprecedented success of the company, which included meeting all clinical endpoints already at the early stage of recruiting half the patients (120 patients out of a full cohort of 240).
Asaf Alperovitz, CEO of Allium Group: “Receiving FDA clearance to market the WIRION system in the US for the carotid clinical indication is a major achievement for Allium. This is the most important milestone towards implementing Allium’s business strategy of leveraging Gardia’s unique technology and solution while broadening the range of relevant clinical indications and maximizing market potential. In the next phase we plan on penetrating the US market in collaboration with a leading strategic partner. Allium plans to promote an engagement with a leading industry partner with global distribution and proven ability to market products in Gardia’s field of activity that will allow the maximization of the clinical and commercial potential of the WIRION® system.”
“The success in achieving all clinical endpoints, 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 favorable feedback from leading European physicians. The system includes significant competitive advantages over other FDA cleared embolic protection devices of world leading companies.”
Alperovitz further added: “I would like to take this opportunity to thank the employees, entrepreneurs and investors for their professional and dedicated work throughout the years that led to the major achievement of obtaining FDA clearance.”
About the WIRION® System:
The WIRION® system is a unique, patent-protected embolic protection filter-type system that protects against blood clots and emboli produced during catheterization 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.
The WIRION® system is approved for marketing in the US for the clinical indication of emboli protection during carotid artery catheterization procedures and in Israel (AMAR) and Europe (CE Mark) for widespread use in all cardiovascular catheterization procedures.
The WIRION® system with its variety of unique features constitutes the next generation of emboli protection devices and may be used for a variety of therapeutic indications, including catheterization of the carotid arteries, leg arteries, renal arteries, TAVI and SVG.
About Allium Medical
Allium is an Israeli company that specializes in minimally invasive medical solutions and presents a variety of technologies and product lines in this area. The Company’s strategy is to create value by expanding the basis of internal developments and by purchasing product lines and additional technologies. The Company is run by leading professionals with knowhow and experience in rapid promotion of products, from the development stage to the commercial stage, while ensuring long-term financing and economies of scale.
Contact:
Asaf Alperovitz, CEO
Allium Medical Solutions Ltd.
Tel.: +972-4-6277166, Ext. 101
Cell: +972-54-7777803
SOURCE Allium Medical
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