CERENOVUS Launches NIMBUS™ Geometric Clot Extractor to Remove Tough Clots

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IRVINE, CA – [October 7, 2020] – CERENOVUS, part of Johnson & Johnson Medical Devices Companies*, today announced the European launch of CERENOVUS NIMBUS™, designed to remove tough clots for successful revascularization in patients with acute ischemic stroke caused by a large vessel occlusion.

Ischemic strokes account for 85%1 of all strokes and up to 46%2 are caused by a large vessel occlusion (LVO). Strokes caused by LVO have devasting consequences – they are responsible for 60% of patient dependency due to disability and more than 90% of mortality.3

Mechanical thrombectomy (MT), a minimally invasive procedure, is the recommended treatment option for acute ischemic stroke4; however, successful recanalization is not achieved within 3 passes or not at all, in approximately 25% of thrombectomy cases10 due, in some cases, to the inability to remove a tough clot. Each attempt is associated with an increased risk of vessel injury and potential impact on clinical outcomes.

CERENOVUS Nimbus is designed to remove tough clot.5 The device is designed with two different design features6 to maximize tough clot removal : a proximal spiral section and distal barrel section6. The spiral section is specifically designed to maximize blood vessel lumen coverage and device-clot interaction7, providing engagement with the clot and facilitate dislodgement of resistant clots8. Through this unique design6 NIMBUS has the potential to improve reperfusion rates and reduce the number of passes required in tough clot cases, which may lead to improvement in patient outcomes8.

“The performance of MT devices varies according to the composition and characteristics of the occluding thrombus and we know that retrieving fibrin rich clots and restoring flow is challenging,” said Dr. Hannes Nordmeyer, Radprax Neurocenter, Solingen, Germany**. “Having a device specifically designed to retrieve tough clots for successful revascularization may improve clinical outcomes and advance stroke treatment.”

NIMBUS is the latest addition to join CERENOVUS Stroke Solutions™ - a suite of technologies designed with compatibility in mind to help physicians perform mechanical thrombectomy procedure. Launched at ESMINT 2020, CERENOVUS Stroke Solutions™, includes CEREBASE™ DA Guide Sheath, EMBOVAC™ Catheter and EMBOTRAP III Revascularization Devices.

“Using the research from our Neuro Thromboembolic Initiative (NTI), we have been able to address the critical unmet clinical need of tough clot retrieval,” said Mark Dickinson**, Worldwide President, CERENOVUS. “NIMBUS gives physicians an additional treatment option for tough clot composition. Our latest innovation demonstrates our commitment to ensuring physicians have the most advanced tools in their hands to change the trajectory of stroke.”

Strokes are the second leading cause of death globally, with estimates suggesting that by 2035 the number of stroke deaths across Europe will increase by 45%9. Over half of stroke survivors become chronically disabled, jeopardizing their quality of life and placing an economic burden on healthcare systems. In the European Union alone the total cost of stroke was estimated at €45 billion in 20159.

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.

* 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.

** Dr. Hannes Nordmeyer a paid consultant to CERENOVUS

***Mark Dickinson is an employee of Biosense Webster, Inc.

Important Information: Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, warnings and precautions.

154104-200924 EMEA
© CERENOVUS 2020

 

References

1) Ischaemic stroke. Stroke Association. Stroke.org.uk. https://www.stroke.org.uk/what-is-stroke/types-of-stroke/ischaemic-stroke. Last accessed July 2020.
2) Smith WS, Lev MH, English JD, et al. Significance of large vessel intracranial occlusion causing acute ischemic stroke and TIA. Stroke. 2009;40(12):3834-3840.
3) Malhotra K, Gornbein J, Saver JL. Ischemic Strokes Due to Large-Vessel Occlusions Contribute Disproportionately to Stroke-Related Dependence and Death: A Review. Front Neurol. 2017;8:651. Published 2017 Nov 30. doi:10.3389/fneur.2017.00651
4) Parthasarathy R and Gupta V. Ann Indian Acad Neurol. 2020 Jan-Feb 23(1): 13–19. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7001454/. Last accessed online September 2020.
5) Fennel et al, What to do about fibrin rich 'tough clots'? Comparing the Solitaire stent retriever with a novel geometric clot extractor in an in vitro stroke model, JNIS 2018.
6) Neuravi, TR426 Tough Clot Definition, Rev 1, Sept 2020. Neuravi, Nimbus IFU CS071-01, Rev 6. Neuravi, Nimbus, Revascularization Device Design Dossier Supplement DD001/S003, July 2018
7) Nimbus IFU CS071-01 Rev 06. DD001/S003: Neuravi Revascularization Device Design Dossier Supplement 2018
8) Fennell VS, Setlur Nagesh SV, Meess KM, et al, Surgery, What to do about fibrin rich ‘tough clots’? Comparing the Solitaire stent retriever with a novel geometric clot extractor in an in vitro stroke model. Journal of NeuroInterventional 2018;10:907-910.
9) Kings College London for The Stroke Alliance for Europe (SAFE). The Burden of Stroke in Europe Report.
10) Fennel et al, What to do about fibrin rich 'tough clots'? Comparing the Solitaire stent retriever with a novel geometric clot extractor in an in vitro stroke model, JNIS 2018. Internal calculation of percentages based on 3 papers. Neuravi, TR426 Tough Clot Definition, Rev 1, Sept 2020. Zaidat et al, Primary Results of the Multicentre ARISE II Study (Analysis of Revascularization in Ischemic Stroke, With EmboTrap), Stroke 2018. Lapergue et al, Effect of Endovascular Contact Aspiration vs Stent Retriever on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion, The ASTER Randomized Clinical Trial, JAMA 2017. Turk et al, Aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for a large vessel occlusion (COMPASS): a multicentre, randomised, open label, blinded outcome, non-inferiority trial, Lancet 2019


* A tough clot is an adherent, durable thrombus that has high stiffness making it resistant to endovascular thrombectomy. General characteristics of these clots are that they are fibrous and consist of few RBCs. In vitro thrombectomy simulation with tough clots result in inferior revascularization rates compared to more compliant clots.
Tough clot defined as per TR426 Rev 1, Sept 2020
*in vitro study Fennell VS, Setlur Nagesh SV, Meess KM, et al. What to do about fibrin rich ‘tough clots? Comparing the Solitaire stent retriever with a novel geometric clot extractor in an in vitro stroke model". Journal of NeuroInterventional Surgery 2018;10:907-910.

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