Concentric Medical, the manufacturer and marketer for ischemic stroke intervention solutions, has received regulatory approval in both Europe (CE Mark) and Canada for its Trevo System for acute ischemic stroke.
Concentric Medical said that EU centers have began initial clinical evaluation of the Trevo System following receipt of CE Mark in late 2009. Numerous cases have been performed and early clinical feedback continues to be positive.
Maria Sainz, president and CEO of Concentric Medical, said: “I am thrilled that Concentric has received these approvals and that physician feedback on our initial cases has been so encouraging. These approvals combined with the positive feedback will allow us to introduce the Trevo System to customers in Europe and Canada in the near future.”
California-based Concentric Medical manufactures and markets minimally invasive devices that are delivered into the brain to restore blood flow by removing blood clots that cause ischemic stroke. Its devices are available in over 500 stroke centers around the world, and have been the subject of several clinical studies.
Trevo System is a thrombus retrieval system. The main component of the Trevo System is a stentriever, a retrieval device that removes clots causing stroke.