Cerus Endovascular Enrolls First Patients in CERUS Study to Treat Intra-Cranial Aneurysms Using Contour Neurovascular System™ to Reduce the Risk of Rupture
November 15, 2018
Fremont, California and Oxford, United Kingdom, November 13, 2018 – Cerus Endovascular Ltd., a privately held medical device company engaged in developing interventional neuroradiology devices and delivery systems to treat acute, life-threatening intracranial aneurysms, today announced enrollment of the first patients in the CERUS Study (Contour Neurovascular System European Pre-Market Unruptured Aneurysm Study). The CERUS study is designed to assess the safety of the company’s Contour Neurovascular System™ , which is designed to reduce the risk of rupture when treating patients with intra-cranial aneurysms. Intracranial aneurysms occur at the rate of nine per 100,000 with a wide range; in some countries, up to 20 per 100,000 (According to Karger Publishers in Basel, Switzerland, a globally active medical and scientific publishing company).
CERUS is a prospective, 30-patient, single-arm, multi-center, pre-market trial. The study is expected to complete enrollment within the next four months and is being conducted at 10 leading European neurological centers in Germany, France, Austria and Denmark. Co-principal investigator, Prof. Dr. Thomas Liebig,, of Ludwig Maximillian’s University Hospital, Munich has performed three of the first four cases with the fourth performed at University Hospital Schleswig-Hostein, Kiel.
When asked about his impression, Prof. Liebig said, “The Contour System combines the benefits of flow disruption and redefinition of the aneurysm-to-parent vessel- border without any material in the parent artery. Thus, it doesn´t mandate long-term antiplatelet therapy. Sizing was straightforward in these first cases and was done with regard to the neck only since the Contour does not aim for bulk replacement of the aneurysmal cavity. Angulation and irregularity of the aneurysm dome seemed to play a lesser role, as well. We are aware of the need for a more valid database with more cases to support these impressions but at the moment we are quite content with our initial experience and look forward to the Co-investigators experiences and to the first control visit of the patients we have treated so far.”
About the Contour Neurovascular System™
The Contour Neurovascular System is a next generation intra-saccular flow diverter and flow disruptor which targets the neck of the aneurysm. Intra-saccular flow diverters divert blood flow from the aneurysm and promotes healing, thereby reducing the risk of aneurysm rupture, a main cause of haemorrhagic stroke. The device is easily positioned and can be re-positioned should more optimal device positioning be warranted. Accurate positioning of the device and effective delivery and deployment are important factors in the successful treatment of intracranial aneurysms. After deployment, the device conforms to the wall of the lower hemisphere of the aneurysm and across the neck sealing the neck opening.
The Contour Neurovascular System™ is for investigational use only.
About Cerus Endovascular
Cerus Endovascular is a privately held, 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, the intracranial aneurysm. The company’s first 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. The company also is developing a pipeline of complementary devices, leveraging the design concept of the Contour Neurovascular System™ to address the myriad variations in the size, type and location of cerebral aneurysms.
Melody A. Carey
Rx Communications Group, LLC