Surgical Robotics Technology
CERENOVUS Inc., an emerging leader in neurovascular care and part of Johnson & Johnson MedTech has announced the launch of its 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,i 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.
* 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
i. 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.
- Derdeyn 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.
- Natarajan 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.
- Spetzler 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.
- Loh 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.
- Velat 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.
Source: CERENOVUS Inc.
