CERENOVUS CEREPAK Detachable Coils Released in U.S.

CERENOVUS Inc., part of Johnson & Johnson MedTech,¹ announced the U.S. availability of the new CEREPAK Detachable Coils, and the first patient cases using the product. 
 
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 delivery system designed for ease of use and reliable detachment,³ next-generation microcatheter stability,⁴ effortless tracking through tortuous anatomy,⁴ 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, M.D.,* 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, M.D.,* 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 United States 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.
 
CERENOVUS Inc., part of Johnson & Johnson MedTech, is an emerging leader in neurovascular care. CERENOVUS offers a portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke. 
 
* 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 and Drug Administration (FDA) requirements. 
 
References
¹ Johnson & Johnson MedTech comprises the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson. CERENOVUS is part of Johnson & Johnson MedTech.
² 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. .
³ Based on benchtop testing, 103504180 Rev 4, 103504180 Rev 4, 103876377 Rev 1.
⁴ Based on benchtop testing in 103876377 Rev 1.
ⁱ 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.
ⁱⁱ 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. 
ⁱⁱⁱ 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.
^iv Cerebral Aneurysms Fact Sheet. National Institute of Neurological Disorders and Stroke. 2021.
^v Endovascular Coiling for Brain Aneurysms. Johns Hopkins Medicine.