Wallaby Medical announces CE Mark approval and FDA 510(k) clearance of its differentiated embolic coil system, the Avenir Coil System. The intended use for the Avenir Coil System is for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Avenir Coil System is also intended for arterial and venous embolization in the peripheral vasculature.
The Avenir Coil System offers a full line of coils including exceptional stable framing coils, extra volume filling coils and ultra-soft finishing coils. Avenir has a streamlined and intuitive, integrated mechanical detachment mechanism with no handle or external energy source required. Furthermore, Avenir’s anatomically adaptive pusher with proprietary multi-filar technology along with its patent pending super-elastic nitinol lasso detachment zone technology facilitates intracranial navigation while minimizing microcatheter kick-out.
The Avenir Coil System has been used to successfully treat over 100 patients in the US, China and Latin America and is expected to be officially launched in the US and Europe later this year.
Professor Youxiang Li of Beijing Tiantan Hospital, one of the largest treatment centers for brain aneurysms in the world, commented, “The Avenir coils provide smooth delivery and exceptional visibility during the procedure. The detachment is intuitive and instantaneous.”
Wallaby Medical Inc. is also pleased to announce they have entered into an exclusive distribution agreement with Phenox for commercialization of the Avenir Coil System in the United States and European markets. Phenox is a developer and manufacturer of innovative treatment options for both hemorrhagic and acute ischemic stroke, with commercial locations in Germany, Ireland, and the United States.
About Wallaby Medical
Wallaby Medical, Inc. is a private company located in Laguna Hills, California that focusses on developing products for treating hemorrhagic and ischemic stroke.