Commercial Sales Across European Union Expected to Begin During Fourth Quarter of 2020
FREMONT, Calif. and OXFORD, United Kingdom - Cerus Endovascular Ltd., a privately-held, commercial stage medical device company, today announced that it has received CE Mark approval for its state of the art CerusEndo MC 021 microcatheter, designed to allow physicians to access tortuous neurovasculature and deliver therapeutic devices to intended targets.
"We remain committed to meeting the ever increasing needs of the interventional neuroradiologist community, and with that in mind, our team has clearly identified a range of increased performance demands required of a go-to intracranial access microcatheter. As a result, we have expanded our key 021 platform so that it can deliver a wider range of devices than it was originally designed for including stents, braided flow diverters and stentrievers, for treatment of both hemorrhagic and ischemic strokes. In particular, the 021 ensures predictable stability and control when delivering the larger and braided devices through the device lumen," stated Dr. Stephen Griffin, President of Cerus Endovascular.
"The systematic expansion of our market reach through the ever increasing accumulation of regulatory approvals is part of our go-to-market strategy," stated Dr. Sam Milstein, Chairman of Cerus Endovascular. "As previously announced, we will continue a limited market release in selected sites, beginning later this year. We are extremely pleased by the response of the medical community to our product portfolio."
The CerusEndo MC 021 microcatheter, which already received approval from the U.S. Food and Drug Administration, is the first of Cerus Endovascular's microcatheter offerings to gain European regulatory approval. The CerusEndo MC 021 microcatheter will be available in multiple distal flexible profiles and is designed to offer superior proximal support, which translates to enhanced deliverability and responsiveness in physicians' hands. Feedback from numerous physicians during the development of the device was extremely encouraging when performing bench top evaluations in highly tortuous anatomical simulations compared to other commercially available catheters.
Cerus Endovascular is a privately-held, commercial stage medical device company engaged in the design and development of highly differentiated and proprietary interventional neuroradiology devices and delivery systems for the treatment of acute, life-threatening neurological conditions, specifically, intracranial aneurysms. The company's first CE Marked product, the Contour Neurovascular System™, is a pre-shaped structure of fine mesh braid with shape memory properties that is delivered to the aneurysm via an endovascular microcatheter. The company has also developed a pipeline of complementary devices, leveraging the design concept of the Contour Neurovascular System™ to address the broad range of sizes, types and locations of cerebral aneurysms with which a patient can present to the clinician. For more information, please go to: www.cerusendo.com .