Irvine-based Biosense Webster, a unit of Johnson & Johnson, said it’s developed a way to help patients and doctors avoid hour-long doses of radiation when using catheters to treat irregular heartbeats.
The Food and Drug Administration has given approval to Biosense Webster to use its ablation products without fluoroscopy, which is a type of medical imaging that shows a continuous X-ray image on a video monitor.
“Doctors doing procedures every day are exposed to a significant amount of radiation,” Tony Hong, vice president, of Preclinical & Clinical Research and Medical Affairs, Cardiovascular & Specialty Solutions at Johnson & Johnson, told the Business Journal.
The company’s key therapeutic product receiving approval without fluoroscopy is called the Thermocool Smarttouch SF catheter, the most used ablation catheter in the world.
A catheter ablation is a minimally invasive procedure used to treat abnormal heart arrhythmias. Ablation is a technique used to strategically destroy abnormal tissue and restore proper function to your heart.
Biosense Webster also received FDA approval for its diagnostic products including: the Carto Vizigo Bi-Directional Guiding Sheath; the Pentaray Nav Eco High Density Mapping Catheter; the Decanav Mapping Catheter; and the Webster CS Catheter.
6 Million Afibs
Atrial fibrillation, known as AFib, is the most common type of cardiac arrhythmia and impacts nearly 37.5 million people worldwide, including 6 million in the U.S.
“Cardiac arrhythmias are a growing epidemic,” Biosense Webster says on its website. “AFib is a progressive disease and if left untreated can get worse over time or lead to other serious complications like heart disease or stroke.”
Biosense Webster says its catheter ablation is a safe and effective procedure to restore the heart’s incorrect electrical signals, which causes an abnormal heart rhythm.
Biosense Webster, which was bought by Johnson & Johnson in 1997, says it’s the global market leader in the diagnosis and treatment of cardiac arrhythmias. Biosense Webster has more than 13,000 employees, including 600 in Irvine.
It is a part of J&J’s Interventional Solutions Department, which generated $4.3 billion in sales in 2022. J&J itself reported $94.9 billion in sales in 2022.
High Radiation
Cardiac ablation procedures for the treatment of atrial fibrillation usually require fluoroscopy to guide the advancement and positioning of catheters.
The problem with fluoroscopy is it can result in relatively high radiation doses, especially for complex interventional procedures over long periods of time.
Biosense Webster has developed the Carto 3 mapping and navigation system that provides 3D imaging that doctors can view live to see exactly where the catheter and electrical signals are in the heart, Hong said.
“They can locate the catheter within millimeters,” Hong said. “The FDA approval allows us to promote this product without using fluoroscopy.”
What was crucial to getting FDA approval was the Real AF Registry, which the company calls the “first-of-its kind real-world evidence registry in the electrophysiology field.”
The Registry assesses real-world catheter ablation clinical outcomes, including procedural efficiency, safety, and long-term effectiveness in a broad group of patient populations.
The FDA approval means doctors and patients can avoid using fluoroscopy and instead direct imaging guidance, such as ultrasound.
