Lazarus Effect has announced that the Lazarus Cover accessory device has received CE mark. The Lazarus Cover is a nitinol-mesh cover that surrounds a retriever device and captured material during removal from a blood vessel.
“The Lazarus Cover provides a unique solution to what has been a major limitation of current retrieval systems, and it does so without requiring physicians to switch from their favourite stent or other retriever device,” says Martin Dieck, chairman and chief executive of Lazarus Effect. “It is among a series of disruptive devices Lazarus Effect is developing to overcome longstanding challenges associated with current vascular interventional procedures.”
Stent-based thrombectomy devices have demonstrated success in ‘capturing’ clots within an affected blood vessel, but often lose thrombus as the device is extracted. Recent results from a 500-patient, multi-centre, randomised European ischaemic stroke trial (MR CLEAN), presented at the 9th World Stroke Congress in Istanbul, revealed that direct vascular intervention (97% used retrievable stents) generated better outcomes than standard stroke therapy alone. The study also demonstrated that, despite generating better outcomes for patients, there is still room for improvement in vascular intervention. Clot particles were lost during interventional procedures, resulting in an ischaemic stroke to a new region of the brain 5.6% of the time, vs. 0.4% of the time in the control (i.e., standard therapy) group.
Lazarus Effect plans to launch the Lazarus Cover, which can be used with a variety of available retriever devices, in Europe during Q1 2015.
The US Patent and Trademark Office recently issued a new patent covering core technology behind the Lazarus Cover, as well as the Lazarus ReCover device. The Lazarus Cover is a generalised device and can be used with a number of retriever types, whereas the ReCover is designed specifically for the retrieval of thrombus during an ischaemic stroke.