Biosense-Webster-CARTO-Vizigo-Sheath (Medical Device News Magazine)
Biosense Webster-CARTO-Vizigo Sheath (Medical Device News Magazine)

Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of heart arrhythmias and part of Johnson & Johnson Medical Devices Companies*, announced today that its CARTO VIZIGO Bi-directional Guiding Sheath is now available in the United States. This is the first commercially available steerable guiding sheath that can be visualized on the CARTO 3 System during a catheter ablation procedure, helping electrophysiologists (EPs) reduce dependency on fluoroscopy.

 

A sheath is an introducer routinely used by EPs to facilitate catheter access, stability, and tissue contact when targeting sites for catheter ablation to treat conditions such as atrial fibrillation. Many EPs rely on fluoroscopy to identify the location of the sheath, therefore requiring use of lead to protect themselves from radiation during the procedure. Research shows up to 62% of medical staff suffer chronic musculoskeletal pain from wearing these heavy protective garments1. Additionally, patients are exposed to a radiation dose equivalent to 830 chest x-rays during a conventional radiofrequency (RF) ablation procedure2.

CARTO VIZIGO can be visualized on the CARTO 3 System map during an ablation procedure, eliminating the need to depend solely on fluoroscopy to determine its location. It was recently used on a patient at Massachusetts General Hospital (MGH) in Boston.

“We are always looking for ways to improve the care we deliver to our patients,” said Moussa Mansour, MD, director of the atrial fibrillation program at MGH. “One of our overall goals is to reduce dependency on fluoroscopy and gain more directional control and awareness during procedures.”

Sheath visualization is incorporated easily into the EP’s workflow, designed to enhance efficiency during mapping and positioning of the ablation catheter. The smooth tip-to-dilator transition promotes ease of entry into the left atrium during transseptal access, while deflections of 180 degrees in both directions mean increased steerability, which may improve access to hard-to-reach sites.

“We are committed to developing novel technologies and workflows for EPs to reduce their exposure to radiation and help them gain freedom from the orthopedic burden of lead,” said Shlomi Nachman, Company Group Chair of Johnson & Johnson Medical Devices Cardiovascular & Specialty Solutions. “The VIZIGO sheath represents the next step in optimizing the CARTO 3 System experience and enhancing the benefits our customers can reap from our integrated platform of technologies.”

This product can only be used by healthcare professionals in the United States.


References

1 Ref: Goldstein JA Occupational Hazards of Interventional Cardiologists: Prevalence of Orthopedic Health Problems in Contemporary Practice Catheterization and Cardiovascular Interventions 63:407–411 (2004)
2 *Effective dose of 16.6 (6.6-59.2) mSv Ref: Picano et al. Risks Related to Fluoroscopy Radiation Associated with EP Procedures. JAFIB Aug-Sep 2014