Wallaby Medical announced yesterday that it won FDA 510(k) clearance and CE Mark approval in the European Union for its Avenir coil system for intracranial aneurysms and other neurovascular abnormalities.
The Laguna Hills, Calif.-based company also said it inked an exclusive distribution deal with Phenox for the commercialization of Avenir in the U.S. and Europe.
The Avenir device includes framing coils, extra-volume filling coils and soft finishing coils designed for endovascular embolization of intracranial aneurisms, arteriovenous malformations and arteriovenous fistulae, among other neurovascular abnormalities, the company said.
Wallaby’s technology is designed to facilitate intracranial navigation and minimize microcatheter kick-out while requiring no external energy source. The system has been used to successfully treat over 100 patients in the U.S., China and Latin America, Wallaby Medical said in a release.
“The Avenir coils provide smooth delivery and exceptional visibility during the procedure. The detachment is intuitive and instantaneous,” Youxiang Li of Beijing Tiantan Hospital said in prepared remarks.
The company expects to roll out the Avenir coil system in the U.S. and Europe later this year.
The company also announced that they plan to entered into an exclusive distribution agreement with Phenox for commercialisation of the Avenir coil system in the USA and European markets.