Lazarus Effect's Cover Device Approved in Europe

November 6, 2014—Lazarus Effect, Inc. announced that the company’s Lazarus Cover accessory device has received European CE Mark approval. The device is a nitinol mesh cover that surrounds a retriever device and captured material during removal from a blood vessel. Lazarus Effect plans to launch the Lazarus Cover in Europe during the first quarter of 2015.

The Lazarus Cover is a generalized device and can be used with a variety of the available retrievers. The Lazarus Cover, Lazarus ReCover (which is designed specifically for the retrieval of thrombus during an ischemic stroke), and the Lazarus Funnel guide catheter have received CE Mark approval for use in Europe. The Funnel is also cleared for use in the United States. Neither the Cover nor the ReCover is approved for sale in the United States, advised Lazarus Effect.

The company noted that the MR CLEAN trial revealed that there remains room for improvement in vascular intervention to generate better outcomes for patients. The results from MR CLEAN, a 500-patient, multicenter randomized European ischemic stroke trial, were presented in October at the 9th World Stroke Congress in Istanbul, Turkey. Although the study showed that direct vascular intervention (97% used retrievable stents) generated better outcomes than standard stroke therapy alone, it also demonstrated that clot particles were lost during the interventional procedures, resulting in an ischemic stroke to a new region of the brain 5.6% of the time versus 0.4% of the time in the control (standard therapy) group.