Next-generation intermediate catheter, CEREGLIDE™ 71 Intermediate Catheter with TruCourse™, now available across the U.S.
Irvine, CA – February 7, 2024 – CERENOVUS, Inc., part of Johnson & Johnson MedTech,i announced today the launch of CEREGLIDE™ 71 Intermediate Catheter, a next-generation intermediate catheter with TruCourse™ indicated for the revascularization of patients suffering from acute ischemic stroke. CEREGLIDE 71 Intermediate Catheter is the latest innovation in a planned CEREGLIDE Family of Catheters to join the CERENOVUS STROKE SOLUTIONS™ portfolio,ii and is optimized for effective direct aspiration and for the delivery of compatible stent retrievers,iii including the EMBOTRAP™ III Revascularization Device, into the neurovasculature.
Acute ischemic strokes account for 85% of all strokes worldwide.1 By utilizing aspiration catheters during thrombectomy procedures, physicians can restore blood flow in the brain by directly withdrawing a blood clot or using the catheter in combination with a stent retriever. However, in nearly 50 percent of cases, challenging features, such as anatomy, can impact assess to the clot, procedure time, recanalization success, and clinical outcomes.2
CEREGLIDE 71 Intermediate Catheter is equipped with TruCourse Technology to increase flexibility of the device and is designed to help physicians with improved navigation and access to clots, even in challenging anatomical conditions.iv,v Part of CERENOVUS STROKE SOLUTIONS, CEREGLIDE 71 Intermediate Catheter with TruCourse provides physicians with optimal compatibility,vi durable delivery,vii and reliable trackabilityv during thrombectomy procedures.
"In the rapidly evolving landscape of neuroendovascular stroke care, staying on the cutting edge is crucial for advancing the field and ensuring physicians have the tools to navigate complex patient anatomy" said Fawaz Al-Mufti*, MD, Interventional Neurologist, Director of the Neuroendovascular Surgery Fellowship, Westchester Medical Center/New York Medical College. “Balancing trackability, support, and aspiration efficacy is crucial in overcoming the challenges of swift clot access during endovascular thrombectomy. As the global first user, in initial use, CEREGLIDE 71 Intermediate Catheter does just that. It impressively navigates, accesses occlusion sites, and engages with effectiveness to aspirate clots, rapidly restoring blood flow in the patient's brain - potentially a life-saving intervention."
Devices within the CERENOVUS STROKE SOLUTIONS portfolio are developed by using the company’s expert stroke science insights from its Neuro Thromboembolic Initiative (NTI). The result is products that have been tested in models that recreate real-world scenarios and seek to further address clinical unmet need. CEREGLIDE 71 Intermediate Catheter will also be included in the next phase of the CERENOVUS EXCELLENT Registry, a real-world registry focused on studying stroke-inducing blood clot removal by mechanical thrombectomy.
“CEREGLIDE 71 Intermediate Catheter is specifically designed to glide through challenging anatomical conditions,” said Mark Dickinson, Worldwide President, CERENOVUS. “Developed through robust research and clinical insights, our team designed a catheter for physicians that addresses unmet clinical needs by providing reliable trackability, durable delivery and the versatility for both direct aspiration and stent-retriever use – even in the most challenging anatomical conditions.”
As part of ongoing sustainability efforts, CEREGLIDE 71 Intermediate Catheter will utilize electronic instructions for use (e-IFUs).** E-IFUs are expected to help reduce CERENOVUS’ environmental footprint, lower CO2 emissions caused during shipment and facilitate a reduction in healthcare systems’ post-consumer recycling and medical waste disposal.
CEREGLIDE 71 Intermediate Catheter is now commercially available in the U.S. For more information visit here.
CERENOVUS, Inc., 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 cerenovus.com and connect on LinkedIn and X.
About Johnson & Johnson MedTechi
At Johnson & Johnson MedTech,i 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, visit JJMT.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding CERENOVUS CEREGLIDE™ 71 Intermediate Catheter. 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., Medical Device Business Services, 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 1, 2024, 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 sec.gov, 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.
* Dr. Al-Mufti is a paid consultant for CERENOVUS. He has not been compensated in connection with these cases.
** Printed instructions for use (IFUs) are available at request per U.S. Food & Drug Administration (FDA) requirements. Visit e-ifu.com for more information.
i. Johnson & Johnson MedTech comprises the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
ii. CERENOVUS STROKE SOLUTIONS™ includes PROWLER® EX, EMBOGUARD™, CEREBASE®, EMBOTRAP™ III. EMBOGUARD™ and CEREBASE® are not compatible and should not be used together.
iii. Based on internal benchtop testing in a clinically relevant silicone flow model.
iv. TruCourse™ is a proprietary technology used to increase flexibility of the device.
v. More trackable than Sofia Plus, React 71, Catalyst 6 and Large Bore Catheter based on physician evaluation in a clinically relevant silicone flow model. Lower Track forces in a clinically relevant silicone flow model compared to Zoom 71.
vi. Compatible with commonly sold base catheters ≥0.085" ID.
vii. More resistant (better kink resistance during intra-procedural use) than Sofia Plus and React 71 based on physician evaluation in a clinically relevant silicone flow model.
- “Ischaemic stroke”. Stroke Association. Stroke.org.uk.
- Penide, J., Mirza, M., McCarthy, R. et al. Systematic Review on Endovascular Access to Intracranial Arteries for Mechanical Thrombectomy in Acute Ischemic Stroke. Clin Neuroradiol 32, 5–12 (2022).
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. 2024. All rights reserved. US_CNV_ISCH_302065