US FDA approves several Biosense Webster ablation devices for zero-fluoroscopy procedures

2023-08-07

放射疗法上市批准

The AFib products approved by the FDA include Thermocool Smarttouch Catheter, Pentaray Nav ECO High Density Mapping Catheter, DECANAV Mapping Catheters, and Webster CS Catheter, along with CARTO VIZIGO Bi-Directional Guiding Sheath The FDA expanded approva is based on the REAL AF registry. (Credit: jesse orrico on Unsplash) Biosense Webster, a company of Johnson & Johnson MedTech, has received the US Food and Drug Administration (FDA) approval for multiple atrial fibrillation (AFib)AFib) ablation devices for use without fluoroscopy. The AFib products include Thermocool Smarttouch Catheter, Pentaray Nav ECO High Density Mapping Catheter, DECANAV Mapping Catheters, and Webster CS Catheter, along with CARTO VIZIGO Bi-Directional Guiding Sheath. Fluoroscopy is an imaging technique that uses continuous X-ray images on a monitor to obtain real-time moving images of the interior of an object. It is widely used in different diagnostic examinations and therapeutic procedures and involves relatively high radiation doses, especially for complex interventional procedures. The FDA approval for zero-fluoroscopy workflow allows direct imaging guidance, such as ultrasound, for use as an alternative to fluoroscopy. With the reduced fluoroscopy, the workflow would lower the radiation exposure, reducing the cancer risk in the long term along with the risk of musculoskeletal pain due to heavy PPE. Biosense Webster president Jasmina Brooks said: “The label change approved by the FDA underscores that the Biosense Webster integrated ecosystem, anchored by the CARTO 3 mapping and navigation system, together with our diagnostic and treatment catheters, enables workflows with zero fluoroscopy, which improves safety, and efficiency of cardiac ablation procedures. “As a result of this update, our teams can now proactively discuss the fluoroscopy alternative workflow with our customers to reinforce the benefits of the Biosense Webster portfolio of products.” The US FDA expanded the label indication based on an observational multicentre registry (REAL AF) that evaluated the real-world catheter ablation clinical outcomes. The study assessed the procedural efficiency, safety, and long-term effectiveness of novel radiofrequency (RF) technologies in treating diverse populations of paroxysmal AFib AFib patients. According to the company, cardiac arrhythmias are a growing epidemic, and AFib AFib is the most common type of cardiac arrhythmia, which may lead serious complications, if left untreated. The catheter ablation is a safe and effective procedure for restoring the heart’s abnormal electrical signals, which lead to an irregular heart rhythm. Johnson & Johnson preclinical and clinical research and medical affairs, cardiovascular and speciality solutions vice president Anthony Hong said: “At Biosense Webster, we are committed to advancing innovative technologies that enable safe, effective, and efficient cardiac ablation procedures, as well as expanding the body of evidence supporting how our technologies are used to improve patient lives. “Our novel approach to evidence generation, utilising real-world evidence from the REAL AF Registry, has helped us secure regulatory approval for our fluoroscopy alternative workflow, and I’m looking forward to utilising this approach in the future to lower study costs and achieve faster regulatory milestones.”

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