. Several products developed by Biosense Webster, which is part of J&J MedTech, got the OK for a"zero fluoroscopy workflow" from the FDA, meaning live X-ray imaging will no longer be needed during catheter insertion procedures. Instead of using X-rays to insert Biosense catheters, medical professionals can now use ultrasound to guide treatments.
Using fewer X-rays, or fluoroscopy, lowers radiation exposure for both patients and medical professionals. Currently, doctors and medical staff who work in treatment rooms that specialize in treating relevant heart procedures often, which can lead to problems like eye issues, cancer, and bone injuries. This FDA approval helps address the recurring occupational hazard.
This move by the FDA marks the first and only approval of its kind. The thumbs up was based on data from clinical trials and research from the REAL AF Registry, or the real-world evidence registry in the electrophysiology field. The data backed how well the treatment works in real-life situations. The new method will only apply for Biosense products like the