Company Also Receives European CE Mark Approval for Novel Stroke Technology Designed for Difficult to Extract Blood Clots
IRVINE, Calif., Dec. 10, 2018 — 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]
About CERENOVUS
CERENOVUS, part of Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke. For more information, visit www.cerenovus.com.
About Johnson & Johnson Medical Devices Companies
As the world’s most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopaedics, vision and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. For more information, visit www.jnjmedicaldevices.com.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the EXCELLENT Registry. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” in the company’s most recently filed Quarterly Report on Form 10-Q, and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online atwww.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Johnson & Johnson Medical Devices Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
*Comprising the surgery, orthopaedics, vision and interventional solutions within the Johnson & Johnson’s Medical Devices segment. CERENOVUS is part of the Johnson & Johnson Medical Devices Companies.
**Daniella Cramp is an employee of Biosense Webster, Inc.
[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.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
Caution: US law restricts this device to sale by or on the order of a physician.
EMBOTRAP Manufacturer
Neuravi Ltd.
Block 3, Ballybrit Business Park
Galway, H91 K5YD
Ireland
© CERENOVUS 2018. Rights Reserved.
SOURCE CERENOVUS
