September 13, 2019
Wallaby Medical's Avenir Coil System Approved in Europe and the United States
September 13, 2019—Wallaby Medical Inc. announced European CE Mark approval and United States FDA 510(k) clearance of the company's Avenir differentiated embolic coil system, which is intended 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 company expects to launch the device in the United States and Europe later this year.
Wallaby, which is based in Laguna Hills, California and Shanghai, China, also announced an exclusive distribution agreement with Phenox GmbH for commercialization of the Avenir coil system in the United States and European markets. Phenox has commercial locations in Germany, Ireland, and the United States, and is a developer and manufacturer of treatment options for hemorrhagic and acute ischemic stroke.
According to the company, the Avenir system offers a full line of coils, including exceptional stable framing coils, extra volume filling coils, and ultra-soft finishing coils. The device has a streamlined and intuitive, integrated mechanical detachment mechanism with no handle or external energy source required. Furthermore, Avenir’s anatomically adaptive pusher with multifilar technology and superelastic nitinol lasso detachment zone technology facilitates intracranial navigation while minimizing microcatheter kick-out.
Professor Youxiang Li, MD, of Beijing Tiantan Hospital in Beijing, China, commented in the company's announcement, “The Avenir coils provide smooth delivery and exceptional visibility during the procedure. The detachment is intuitive and instantaneous.”