IRVINE, CA – March 28, 2024 – CERENOVUS Inc., an emerging leader in neurovascular care and part of Johnson & Johnson MedTech*, today announced the launch of TRUFILL™ n-BCA Liquid Embolic System Procedural Set. The latest addition to the CERENOVUS hemorrhagic stroke portfolio now offers TRUFILL™ n-BCA Liquid Embolic System as a new procedural set that includes two configurations and the accessories needed to prep and deliver n-BCA Liquid Embolic System in one sterilized set, creating streamlined procedure preparation.
“The treatment of neurovascular disease can be highly complex,” said Mark Dickinson, Worldwide President, CERENOVUS. “Our new TRUFILL n-BCA Liquid Embolic System Procedural Set was designed to address real-world challenges in the treatment of hemorrhagic stroke – simplifying procedure preparation and making it easier for physicians to better serve their patients.”
TRUFILL n-BCA Liquid Embolic System is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via super-selective catheter delivery when pre-surgical devascularization is desired. By combining this product as a procedure set, it includes 1mL and 3mL syringes, a glass beaker for mixing, an 18 G blunt fill needle, 21 G hypodermic needles and syringe labels.
“The procedural set was easy to use and eliminated the guesswork and sourcing for materials that are necessary to prepare for the procedure,” said Johanna Fifi**, MD, Mount Sinai, who completed one of the first cases using TRUFILL n-BCA Liquid Embolic System Procedural Set.
Pre-surgical devascularization with embolic agents can be used to reduce the risk of bleeding during surgery, making inoperable AVMs operable, or to reduce the size of the AVM such that it can be later surgically resected.1,2,3,4 The TRUFILL n-BCA Liquid Embolic System offers customizable solutions for each patient, flexibility for physicians and demonstrates lower total fluoroscopy time5† and may lower overall procedural costs. Compared to its competitors, TRUFILL n-BCA has demonstrated a low incidence of microcatheter retention and the ability to customize the solution.4
The TRUFILL n-BCA Liquid Embolic System Procedural Set received FDA approval on September 29, 2023. The procedural set is now available for market release in the U.S. For more information, visit here.
About CERENOVUS
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 X.
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 http://www.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 TRUFILL™ n-BCA Liquid Embolic System Procedural Set. 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 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.
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© CERENOVUS 2024
References
†A retrospective study reported mean fluoroscopy time with TRUFILL n-BCA of 37 ± 21 minutes was significantly shorter than with ONYX™ LES of 57 ± 26 minutes (p<0.0001). The third-party trademarks used herein are the properties of their respective owners.
1Derdeyn CP, Zipfel GJ, Albuquerque FC, Cooke DL, Feldmann E et al. (2017) Management of Brain Arteriovenous Malformations: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke 48 (8): e200-e224.
2Natarajan SK, Born D, Ghodke B, Britz GW, Sekhar LN (2009) Histopathological changes in brain arteriovenous malformations after embolization using Onyx or N-butyl cyanoacrylate. Laboratory investigation. J Neurosurg 111 (1): 105-113.
3Spetzler RF, Martin NA, Carter LP, Flom RA, Raudzens PA et al. (1987) Surgical management of large AVM’s by staged embolization and operative excision. J Neurosurg 67 (1): 17-28.
4Loh Y, Duckwiler GR, Onyx Trial I (2010) A prospective, multicenter, randomized trial of the Onyx liquid embolic system and N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations. Clinical article. J Neurosurg 113 (4): 733-741.
5Velat GJ, Reavey-Cantwell JF, Sistrom C, Smullen D, Fautheree GL et al. (2008) Comparison of N-butyl cyanoacrylate and onyx for the embolization of intracranial arteriovenous malformations: analysis of fluoroscopy and procedure times. Neurosurgery 63 (1 Suppl 1): ONS73-78; discussion ONS78-80.
*CERENOVUS, Inc. is a part of Johnson & Johnson MedTech which comprises the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment
** Dr. Fifi is a paid consultant for CERENOVUS
Media Contact:
Ryan Carbain
732.232.9062
rcarbain@its.jnj.com