Wallaby Medical has announced 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 embolisation 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 embolisation in the peripheral vasculature.
According to a press release, the Avenir coil system offers a full line of coils including exceptional stable framing coils, extra volume filling coils and ultra-soft finishing coils. The press release states that 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 minimising microcatheter kick-out.
The Avenir coil system has been used to successfully treat over 100 patients in the USA, China and Latin America and is expected to be officially launched in the USA and Europe later this year.
Youxiang Li (Tiantan Hospital, Beijing, China) says: “The Avenir coils provide smooth delivery and exceptional visibility during the procedure. The detachment is intuitive and instantaneous.”
Wallaby Medical also announced that they have entered into an exclusive distribution agreement with Phenox for commercialisation of the Avenir coil system in the USA 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 USA.