CEREPAK™ is designed to embolize brain aneurysms and is part of the CERENOVUS hemorrhagic portfolio
IRVINE, Calif. – May 1, 2023 – CERENOVUS, Inc., part of Johnson & Johnson MedTech1, today announced the new CEREPAK™ Detachable Coils are commercially available in the U.S. and that the first patient cases have been performed. CEREPAK is the latest innovation to join the CERENOVUS hemorrhagic portfolio and further demonstrates the company’s commitment to treating hemorrhagic stroke.
The CEREPAK Detachable Coils offer three shapes and multiple coil sizes, providing physicians with comprehensive options to embolize brain aneurysms, including coils shaped specifically to achieve concentric aneurysm filling and contribute large volumetric filling.i,ii,iii,2 CEREPAK provides physicians with a state-of-the-art delivery system designed for ease of use and reliable detachment3, next-generation microcatheter stability4, effortless tracking through tortuous anatomy4, and reduction of radiation (fluoroscopy) exposure with fluoro-saver markers.
“I’m privileged to be one of the first users of the new CEREPAK Detachable Coils,” said Osama O. Zaidat, MD*, Director of the Neuroscience and Stroke Center at Mercy Hospital in Toledo, Ohio and study co-principal investigator of the STERLING Registry, “The advancement of greater tools in neurology may improve patient outcomes and my team looks forward to continuing the utilization of CEREPAK coils in our treatment plans.”
This latest addition to the CERNEOVUS portfolio will also be included in the STERLING Registry which is currently collecting real-world data on ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils.
“The CEREPAK Detachable Coils provide important advancements for embolizing brain aneurysms and we’re pleased to expand the STERLING Registry to include this latest CERENOVUS offering,” said Reade De Leacy, MD*, Neurointerventional Radiologist, Associate Professor of Neurosurgery and Radiology, Mount Sinai Health System and study co-principal investigator of the STERLING Registry.
Brain aneurysms are weak spots in blood vessels that have the potential to rupture and cause bleeding within the brain. Such bleeding can lead to complications, including hemorrhagic stroke, permanent nerve damage or death.iv Each year, about 30,000 people in the U.S. suffer from ruptured brain aneurysms.iv The first treatment of choice for intracranial aneurysms is a minimally invasive coiling procedure, where coils are inserted directly into an aneurysm to fill up space and induce clotting to prevent it from rupturing.v
“At CERENOVUS, we push the boundaries of what is possible in stroke care through continuous innovation,” said Mark Dickinson, Worldwide President, CERENOVUS. “Our main goal is to address unmet clinical needs and improve patient outcomes, and we’re proud to announce this latest addition to our hemorrhagic portfolio that furthers our commitment to changing the trajectory of stroke.”
In support of CERENOVUS’ sustainability commitments, CEREPAK is the first product in the company’s U.S. portfolio to utilize electronic instructions for use (e-IFUs)**. E-IFUs are expected to help reduce the company’s environmental footprint, lower CO2 emissions caused during shipment and facilitate a reduction in healthcare systems’ post-consumer recycling and medical waste disposal. Additionally, the CEREPAK mechanical detachment system reduces waste with the elimination of a disposable battery source needed in traditional electromechanical systems.
CEREPAK Detachable Coils are now commercially available in the U.S. For more information on CEREPAK, 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 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 jnjmedtech.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 CERENOVUS CEREPAK™. 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, 2023, 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.
* Drs. Zaidat and De Leacy are paid consultants to Johnson & Johnson MedTech, including in connection with the STERLING Registry. Neither has 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.
- Johnson & Johnson MedTech comprises the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson. CERENOVUS is part of Johnson & Johnson MedTech.
- Studied devices have different names (MICRUSPHERE®, Trufill DCS Orbit®, DELTAPAQ™), but have the same or equivalent microcoil secondary shape as CEREPAK coils on the CEREPAK Delivery System. .
- Based on benchtop testing, 103504180 Rev 4, 103504180 Rev 4, 103876377 Rev 1.
- Based on benchtop testing in 103876377 Rev 1.
- Lee DH et al. Embolization of Cerebral Aneurysms with Spherically Shaped Detachable Microcoils (MicruSphere Microcoil System): A Single Centre Experience. Interv Neuroradiol. 2009 Mar 31;15(1):29‐ 36.
- Mehra, Gounis, Bendok et al. The impact of coil shape design on angiographic occlusion, packing density and coil mass embolization: an in vitro study. 2011 Jan 24.
- Bendok BR, Rahme RJ, Complex Registry G (2013) Complex shaped detachable platinum coil system for the treatment of cerebral aneurysms: the Codman Trufill DCS and Trufill DCS Orbit Detachable Coil System COMPLEX Registry final results. J Neurointerv Surg 5 (1): 54‐61.
- Cerebral Aneurysms Fact Sheet. National Institute of Neurological Disorders and Stroke. 2021.
- Endovascular Coiling for Brain Aneurysms. Johns Hopkins Medicine.
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. 2023