IRVINE, CA – September 9, 2020 – CERENOVUS, part of Johnson & Johnson Medical Devices Companies* today announced that it has launched CERENOVUS Stroke Solutions™, which includes a suite of three devices designed to aid physicians in clot removal procedures. The announcement was made during the virtual European Society of Minimally Invasive Neurological Therapy (ESMINT).
Strokes are the second leading cause of death globally, and account for an estimated 140,000 deaths in the United States each year.[i],[ii] Over half of stroke survivors become chronically disabled placing an estimated $34 billion economic burden on healthcare systems each year in the United States.1,2
CERENOVUS Stroke Solutions™ were designed with compatibility in mind to help physicians perform mechanical thrombectomy procedures. The suite of technologies includes:
- CEREBASE™ DA Guide Sheath, a long guide sheath, designed with more trackability and support to allow physicians to navigate challenging anatomy and secure Distal Access for Geometric Anchoring.[iii]
- CERENOVUS Large Bore Catheter is designed for atraumatic vessel wall interaction to balance trackability with more durability and compatibility. Featuring excellent distal kink resistance in a thin wall design, it allows rapid navigation to the middle cerebral artery based on anatomically optimized design.[iv],[v],[vi]
- EMBOTRAP® III Revascularization Device, the latest generation stent retriever, is designed to engage a wide range of clot types, improve procedural confidence and provide more tailored options to achieve the First Pass Effect (FPE).[vii],[viii] FPE is an independent predictor of good functional outcome and has resulted in faster patient recovery times, which may translate to lower healthcare costs.[ix]
“Stroke is a silent killer that can take a life within minutes, and we designed CERENOVUS Stroke Solutions™ to support physicians in successfully treating their patients efficiently and effectively,” said Mark Dickinson, Worldwide President, CERENOVUS. “We are committed to developing differentiated solutions based on physicians’ real-world experiences to change the trajectory of stroke care.”
CERENOVUS at ESMINT
Interim data from the EXCELLENT registry will be presented focused on the composition of the clots collected. This research on clot science continues to provide the foundation used to inform the design of CERENOVUS Stroke Solutions.
“Not all mechanical thrombectomy procedures are equal and the greatest benefits to patients are observed when reperfusion is achieved from the first pass,” said Professor Kyriakos Lobotesis**, Imperial College Healthcare NHS Trust, London, UK, principal investigator in the EXCELLENT study. “The EXCELLENT registry is a unique study that goes beyond reporting patient outcomes and helps to understand more about clot composition, revascularization rates and clinical outcomes.”
CERENOVUS will also host a virtual symposium on Thursday, Sept. 10 at 10:45 AM CET., “The quest for a total stroke solution. Now in sight?” moderated by Prof. Kyriakos Lobotesis, Imperial College Healthcare NHS Trust, London, UK, with faculty presenters Dr. Fritz Wodarg, University Medical Center Schleswig-Holstein, Kiel, Germany, and Dr. Hannes Nordmeyer, Radprax Neurocenter Solingen, Germany. Registration for the Congress is available at www.esmint.eu/esmint-congress/registration/.
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 and connect on LinkedIn and Twitter.
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, orthopedics, 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 [a new product / PRODUCT NAME] [product development] [optional: provide general description of subject matter of release and/or forward-looking statements]. 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 [OPCO] [, any of the other 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 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither [OPCO / the Johnson & Johnson Medical Devices Companies] nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
* The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, vision and interventional solutions businesses. CERENOVUS is part of the Johnson & Johnson Medical Devices Companies.
** Professor Kyriakos Lobotesis is a paid consultant to CERENOVUS
Important Information: Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, warnings and precautions. Caution: US law restricts this device to sale by or on the order of a physician. Not all products may be available in all markets.
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[i] Donkor, Eric S. “Stroke in the 21st Century: A Snapshot of the Burden, Epidemiology, and Quality of Life.” Stroke Research and Treatment, Hindawi, 27 Nov. 2018, www.ncbi.nlm.nih.gov/pmc/articles/PMC6288566/.
[ii] “Stroke Facts.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 31 Jan. 2020, www.cdc.gov/stroke/facts.htm.
[iii] Not statistically significant in standard position. More trackability and more support than Neuron™ MAX, AXS Infinity LS™, Shuttle®, Fubuki™. More support than Ballast™.
[iv] Rapid Navigation ‐ Good Trackability to MCA: (1) Competitive Test Report 103618595,October 2019 (2) Competitive Test Report 103628641, October 2019.
[v] Variable Braid Density: (1) Competitive Test Report 103628641, October 2019.
[vi] Seamless TransitionZones:1. Competitive Test Report 103628641, October 2019.
[vii] Cell size measurements: TR374 Dimensional and Geometrical Features ET3 Evidence Generation, January 2020.
[viii] P006 EMBOTRAP III Project Charter, DCN # 1259.
[ix] Zaidat, Osama. Economic Impact of the First Pass Effect (FPE) in the Treatment of Stroke with the EMBOTRAP II Device (in ARISE-II). Poster presented at SNIS 2019. https://cslide-us.ctimeetingtech.com/snis2019/attendee/eposter/poster/115?s=pbn.
