Cerenovus Launches EXCELLENT Registry to Analyze Clots and Receives CE Mark Approval for GCE Thrombectomy Device
December 10, 2018—Johnson & Johnson Medical Devices Companies announced that its Cerenovus business has launched the EXCELLENT registry to collect and analyze stroke-inducing blood clots removed from the brain with its Embotrap II revascularization device, a next-generation stent retriever used in mechanical thrombectomy.
According to the company, the EXCELLENT registry will enroll up to 1,000 patients who have experienced ischemic stroke in as many as 50 clinical sites in the United States and Europe. Real-world evidence will be collected on all patients and clots will be preserved and studied to determine how different clot characteristics including size, composition, and density may impact or relate to patient comorbidities, clinical outcomes, and revascularization rates.
The Embotrap II device received FDA clearance in the United States earlier this year and was launched in the United States at the Society of NeuroInterventional Surgery's 15th Annual Meeting held July 23–26 in San Francisco, California. The Embotrap II also has CE Mark approval and has been available in Europe since 2016.
Cerenovus also recently received European CE Mark approval for the Geometric Clot Extractor (GCE) revascularization device. The GCE revascularization device is designed to retrieve various thrombus types, whether hard, fibrin-rich thrombus or soft, red blood cell–rich thrombus. The company is conducting a controlled evaluation study before its European commercial launch to assess its clinical utility and potential advantages over existing technologies.
Although advances in thrombectomy have made the procedure standard practice, approximately 20% or more ischemic stroke cases remain resistant to thrombectomy because of the nature and composition of certain blood clots. The GCE device was developed to address these resistant clots, noted the company.