Home News FDA Greenlights Johnson & Johnson’s X-ray Free Cardiac Treatments

FDA Greenlights Johnson & Johnson’s X-ray Free Cardiac Treatments

by admin
Zero Fluoroscopy Workflow

The FDA has given its seal of approval to Johnson & Johnson’s medical technology subsidiary for an innovative medical process designed to enhance the safety of healthcare professionals while treating atrial fibrillation, a disorder that causes an irregular heartbeat and can lead to stroke or heart failure. The newly approved medical products, devised by Biosense Webster, a division of J&J MedTech, involve a “zero fluoroscopy workflow”. This groundbreaking technique eliminates the need for live X-ray imaging during catheter insertion procedures and instead employs ultrasound guidance.

The minimized use of X-rays, or fluoroscopy, effectively reduces radiation exposure for both patients and healthcare workers. Currently, healthcare professionals involved in heart-related treatments often face excess radiation exposure over time, causing potential issues such as eye complications, cancer, and bone injuries. This latest FDA endorsement effectively tackles this ongoing occupational hazard. Additionally, this approval allows healthcare providers in catheterization labs to forego wearing weighty protective clothing such as lead aprons during the implementation of the new method, thereby decreasing the likelihood of chronic muscle and bone discomfort.

This novel approval by the FDA represents a unique achievement in this field. The decision was influenced by clinical trial data and research from the REAL AF Registry, which gathers real-world evidence in the electrophysiology arena. The gathered data supported the effectiveness of the treatment under real-world conditions. The fresh technique will be applicable solely to Biosense products, including the THERMOCOOL SMARTTOUCH SF catheter – the most frequently utilized ablation catheter – and other related items.

Frequently Asked Questions (FAQs) about Zero Fluoroscopy Workflow

What is the zero fluoroscopy workflow approved by the FDA?

The zero fluoroscopy workflow is an innovative medical process developed by Biosense Webster, a division of J&J MedTech. It is a new approach to atrial fibrillation treatments that removes the need for live X-ray imaging during catheter insertion procedures and instead employs ultrasound guidance.

Which company developed the zero fluoroscopy workflow?

The zero fluoroscopy workflow was developed by Biosense Webster, which is part of Johnson & Johnson’s medical technology division, J&J MedTech.

What are the benefits of the FDA-approved zero fluoroscopy workflow?

The zero fluoroscopy workflow reduces radiation exposure for both patients and healthcare professionals, addressing an ongoing occupational hazard. Additionally, healthcare providers in catheterization labs no longer need to wear heavy protective clothing, reducing the likelihood of chronic muscle and bone discomfort.

What is the role of the REAL AF Registry in this approval?

The REAL AF Registry provided clinical trial data and real-world evidence in the electrophysiology field that supported the effectiveness of the zero fluoroscopy workflow under real-world conditions, influencing the FDA’s approval decision.

Which products will utilize the new zero fluoroscopy workflow?

The zero fluoroscopy workflow will be applicable solely to Biosense products, including the THERMOCOOL SMARTTOUCH SF catheter – the most frequently utilized ablation catheter – and other related items.

More about Zero Fluoroscopy Workflow

You may also like

Leave a Comment