Cerus Endovascular said it has enrolled the first patients in a study 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 intracranial aneurysms.
Intracranial aneurysms occur at the rate of nine per 100,000 with a wide range; in some countries, the rate is up to 20 per 100,000, according to Karger Publishers in Basel, Switzerland, a medical and scientific publishing company.
The Contour system is an intra-saccular flow diverter and flow disruptor that targets the neck of the aneurysm. Intra-saccular flow diverters divert blood flow from the aneurysm and promote healing, thereby reducing the risk of aneurysm rupture, a main cause of hemorrhagic stroke.
Contour is pre-shaped of fine mesh braid with shape memory properties and is delivered to the aneurysm via an endovascular micro-catheter. Accurate positioning of the device and effective delivery and deployment are important factors in the successful treatment of intracranial aneurysms. The device was designed to be easily positioned and can be re-positioned if warranted. After deployment, it conforms to the wall of the lower hemisphere of the aneurysm and across the neck sealing the neck opening, according to Cerus.
The study is a prospective, 30-patient, single-arm, multi-center, pre-market trial. Expected to complete enrollment within the next four months, it is being conducted at 10 neurological centers in Germany, France, Austria and Denmark. Co-principal investigator, Dr. Thomas Liebig of Ludwig Maximillian’s University Hospital in Munich, has performed three of the first four cases, with the fourth performed at University Hospital Schleswig-Hostein in Kiel, Germany.
“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,” Liebig said in a prepared statement. “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.”
The company also is developing a pipeline of complementary devices to address variations in the size, type and location of cerebral aneurysms. The Contour system is for investigational use only.