Johnson & Johnson Medical Devices Companies* today announced that its CERENOVUS business has launched the single largest global registry, 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.
The EXCELLENT Registry will enroll up to 1,000 ischemic stroke patients 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.
“This is a landmark registry study that will provide real-world data on the EMBOTRAP II Device while advancing the scientific community’s understanding of how variations in blood clots correlate with treatment and outcomes,” said Daniella Cramp**, WW CERENOVUS President. “We believe thoughtful and extensive research into the science of blood clots is the key to developing the most effective endovascular treatments and bringing its benefits to the greatest number of stroke patients.”
That extensive clot research conducted by CERENOVUS was the basis for the development of the EMBOTRAP II Device, which features a unique dual-layer design that allows doctors to maintain engagement and control of a broad range of clots with minimal compression during removal. The device was cleared by the FDA in the U.S. earlier this year and has been available in Europe since 2016.
CE Mark Approval of Novel Device for Thrombectomy-Resistant Clots
While advances in thrombectomy have made it standard practice, about 20 percent or more of ischemic stroke cases remain resistant to the procedure due to the nature and the composition of certain blood clots.1 In an effort to fill this clinical need, CERENOVUS has developed the Geometric Clot Extractor (GCE) Revascularization Device, a novel stroke technology shown to retrieve various thrombus types, whether fibrin-rich thrombus (hard) or RBC-rich thrombus (soft). The company received CE mark approval in the European Union for the device earlier this month and is conducting a controlled evaluation study prior to its commercial launch to assess its clinical utility and potential advantages over existing technologies.
“We are excited by both the clinical insights the EXCELLENT Registry will provide and the possibilities for GCE in helping to bring the benefits of mechanical thrombectomy to difficult to treat stroke patients,” said Cramp. “We have a deep commitment to meaningful innovation through the development of evidence-based solutions that give patients the best chance for a high quality of life after stroke.”
Strokes strike nearly 800,000 Americans each year, and is a leading cause of disability, and the fifth leading cause of death.2 For stroke patients, the difference between life and death, and between functional independence and disability, is tied to timely restoration of blood flow to the oxygen-starved brain after a stroke event occurs.3 In the U.S. alone, the economic burden of stroke is estimated at $34 billion annually, which includes the cost of health care services, medications, and lost productivity.4
1 Fennell VS, et al. J NeuroIntervent Surg 2018;0:1–4. doi:10.1136/neurintsurg-2017-013507
2 American Heart Association “Impact of Stroke (Stroke Statistics)” http://www.strokeassociation.org/STROKEORG/AboutStroke/Impact-of-Stroke-Stroke-statistics_UCM_310728_Article.jsp#.WmDsuSOZMQ8 Date Accessed: 03 December 2018.
3 Mayo Foundation for Medical Education and Research (MFMER) “Stroke” https://www.mayoclinic.org/diseases-conditions/stroke/diagnosis-treatment/drc-20350119 Date Accessed: 04 December 2018.
4 Centers for Disease Control “Stroke Fact Sheet” https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_stroke.htm Date Accessed: 03 December 2018.