EXCELLENT study demonstrates real-world benefits of CERENOVUS’ EMBOTRAP™ Revascularization Devices on clinical outcomes and first pass reperfusion
IRVINE, CA – Nov. 18, 2022 – CERENOVUS, Inc., part of Johnson & Johnson MedTech*, today announced positive primary outcomes from the real-world EXCELLENT Registry focused on stroke-inducing blood clot removal by mechanical thrombectomy at the Society of Vascular and Interventional Neurology (SVIN) annual meeting, taking place in Los Angeles, CA from November 16-19, 2022.1
Stroke is the second-leading cause of death worldwide,i with ischemic stroke being the most common type.ii Launched by CERENOVUS in 2018, the EXCELLENT Registry is the largest global acute ischemic stroke registry, which collects patient data, imaging and clots on a per pass basis and leverages independent adjudication by an imaging core lab and clinical events committee. All patients enrolled in the registry were treated with CERENOVUS EMBOTRAP™ II or EMBOTRAP™ III Revascularization Devices as a first line therapy. Offered within the CERENOVUS ischemic portfolio, the EMBOTRAP™ family of devices are next generation stent retrievers designed to remove clots during mechanical thrombectomy procedures. Stent retrievers help achieve first pass recanalization, which is associated with the greatest patient benefits.iii
The EXCELLENT registry aims to advance stroke care by characterizing the EMBOTRAP™ device at multiple hospitals using the technique of choice to reflect current practice patterns, and evaluating the clots retrieved to identify the potential impact different clot compositions can have on patient outcomes. The EXCELLENT data released today comprises 1,000 ischemic stroke patients from 36 sites worldwide. Primary results collected from 2018 to present include:
- Final successful reperfusion2 of 94.5% achieved with mixed techniques
- Over 50% of patients completed procedures with a single pass of EMBOTRAP™
- First pass substantial reperfusion2 of 63% and near complete reperfusion3 of 38.1%
- Good to ideal clinical outcome in 46.8% of patients4
- A very low rate of symptomatic complications5 of 1.6% and 0.6% in cases with a single pass of EMBOTRAP™
“The positive preliminary findings of this research provide real-world results that demonstrate advances are possible in mechanical thrombectomy procedures to treat ischemic stroke,” said Mark Dickinson, Worldwide President of CERENOVUS. “It is encouraging to see these positive results and realize the impact this data can have on improved patient outcomes and changing the trajectory of stroke.”
The EXCELLENT Registry is a large international multicenter cohort of “all-comers,” featuring a wide range of stroke cases, including patients who in the past have not been considered good thrombectomy candidates. The clots will be analyzed by blinded central labs under standard protocol, which furthers prior stroke science research conducted by CERENOVUS’ Neuro Thromboembolic Initiative (NTI). To build on its important discoveries, the EXCELLENT Registry is being expanded to 1,000 additional stroke patients and will include new sites in China and Japan; the expanded study will also include CERENOVUS Large Bore Catheter™/EMBOVAC™ to examine the impact of direct aspiration as a first line treatment and enable researchers to study clots retrieved through both direction aspiration and stent retrievers.
For more information on CERENOVUS’ portfolio, visit Cerenovus Products.
CERENOVUS, part of Johnson & Johnson MedTech, is an emerging 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 MedTech
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized. For more information, visit J&JMedTech.
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 CERENOVUS EMBOTRAP™ II and III Revascularization Devices and the CERENOVUS Large Bore Catheter™/EMBOVAC™. 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 CERENOVUS, Inc., any of the other Johnson & Johnson MedTech 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 January 2, 2022, 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 Johnson & Johnson MedTech nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
* Johnson & Johnson MedTech comprises the surgery, orthopaedics, vision and interventional solutions businesses. CERENOVUS is part of Johnson & Johnson MedTech.
- “The Top 10 Causes of Death.” World Health Organization. 2020.
- Ischaemic stroke. Stroke Association. Stroke.org.uk.
- Jang, Kyoung Min, Choi, Hyun Ho, et al. Clinical outcomes of first-pass effect after mechanical thrombectomy for acute ischemic stroke: A systematic review and meta-analysis. Clinical Neurology and Neurosurgery. Volume 211, December 2021, 107030.
- Results were presented for the first time at the World Stroke Congress in Singapore in October 2022.
- Expanded Thrombolysis In Cerebral Infarction (eTICI) 2b-3.
- Expanded Thrombolysis In Cerebral Infarction (eTICI) 2c-3.
- Modified Rankin Score (mRS) 0-2 or no worsening from baseline.
- Symptomatic IntraCerebral Hemorrhage (sICH) at 24 hours.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
© CERENOVUS, Inc. 2022