FREMONT, Calif. and OXFORD, United Kingdom, July 6, 2017 /PRNewswire/ — Cerus Endovascular Ltd. today announced that it has received CE Mark approval for the commercial sale of its Contour Neurovascular System for the treatment of intra-cranial aneurysms (IAs) across the European Union (EU). The Contour Neurovascular System is a unique, fine mesh braid that is deployed at the neck of the aneurysm sac and provides a combination of flow diversion and flow disruption through a single device implant. The company intends to initiate a controlled commercial rollout in select CE marking countries through a direct sales force during the third quarter of 2017.
“CE Mark approval of our Contour Neurovascular System represents a significant milestone not only for our company, but, more importantly, for the millions of patients worldwide who carry the risks posed by unruptured intra-cranial brain aneurysms,” said J. Todd Derbin, founder, chairman and chief executive officer of Cerus Endovascular. “We have designed the Contour Neurovascular System to deliver significant clinical advantages versus competing technologies. Notably, the system targets the neck of the aneurysm away from the vulnerable dome, it is self-anchoring for stability, it is re-sheathable for precise placement and since it is deployed across the neck, sizing criteria are less stringent, making it easier to use. Further, based on patients treated to date in a compassionate use setting, Contour achieved a 100% implant success rate with an excellent safety profile. Given these demonstrated attributes, we believe that Contour represents a true paradigm shift in the treatment of intra-cranial aneurysms, and we look forward to making this disruptive technology available to physicians in CE marking countries while advancing discussions with regulators in the United States and other key geographies.”
“The evolution of aneurysm treatment, from surgery, to endovascular coils, to mesh baskets, has created new modalities that are less invasive and increasingly effective,” said Dr. Tufail Patankar, consultant interventional neuroradiologist at Leeds General Infirmary in Leeds, UK. “However, even current treatments can be complex and risky. In contrast, the unique design of Contour allows for treatment of the aneurysm with a single, versatile device that can be deployed with existing microcatheter techniques. As a result, fewer maneuvers are required within and around the aneurysm than with other available device classes, such as flow diverters, allowing for safer embolization, reduced rupture rates, shortened procedure times and superior patient outcomes.”
Cerus Endovascular is currently conducting a 45-patient single arm, multi-center pilot trial designed to demonstrate the safety of the Contour Neurovascular System in the treatment of unruptured aneurysms. The study is being conducted at four leading neurological centers in the UK and one in Hungary. With CE Mark approval, the company plans to conduct future prospective clinical trials through the initiation of a Post Approval Study and Registry.
About Cerus Endovascular
Founded in 2013, 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 aneurysm. The company’s first marketed 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 micro-catheter and is currently approved for sale across the EU. The company is also developing a pipeline of complementary devices, leveraging the design concept of the Contour Neurovascular System to address the full range of size, type and location of cerebral aneurysms with which a patient can present to the clinician.
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SOURCE Cerus Endovascular Ltd
