Johnson & Johnson
Johnson & Johnson

FDA approves Johnson & Johnson X-Ray free heart treatments

What To Know

  • Johnson Medical technology division has achieved a significant milestone with FDA approval for a groundbreaking workflow designed to enhance the safety of treating atrial fibrillation, a condition characterized by irregular heartbeats that can lead to stroke or heart failure.
  • Furthermore, the newly approved workflow eliminates the need for medical professionals working in cath labs to wear heavy protective gear like lead aprons, alleviating the risk of long-term muscle and bone pain caused by extended usage.
  • The decision was based on compelling data obtained from clinical trials and research conducted through the REAL AF Registry (Real-World Evidence Registry in the Electrophysiology field).
  • This advancement marks a significant leap forward in medical technology, revolutionizing the way atrial fibrillation is treated and safeguarding the health and well-being of both patients and medical professionals.

Johnson & Johnson Medical technology division has achieved a significant milestone with FDA approval for a groundbreaking workflow designed to enhance the safety of treating atrial fibrillation, a condition characterized by irregular heartbeats that can lead to stroke or heart failure.

This approval specifically applies to several products developed by Biosense Webster, a part of Johnson & Johnson MedTech, and introduces a “zero fluoroscopy workflow” endorsed by the FDA.

As a result, live Johnson & Johnson’s X-ray imaging will no longer be necessary during catheter insertion procedures for treating atrial fibrillation. Instead, medical professionals can rely on ultrasound for precise guidance during treatments.

The adoption of this “zero fluoroscopy workflow” has numerous benefits. By reducing the reliance on Johnson & Johnson’s X-rays or fluoroscopy, both patients and medical professionals experience reduced radiation exposure, minimizing associated risks.

At present, doctors and medical staff working in specialized treatment rooms for heart procedures are often exposed to high levels of radiation over time, leading to potential issues like eye problems, cancer, and bone injuries. The FDA’s approval addresses this recurring occupational hazard and enhances the safety of healthcare providers.

Furthermore, the newly approved workflow eliminates the need for medical professionals working in cath labs to wear heavy protective gear like lead aprons, alleviating the risk of long-term muscle and bone pain caused by extended usage.

It’s worth noting that this FDA approval is unprecedented and stands as the first and only one of its kind. The decision was based on compelling data obtained from clinical trials and research conducted through the REAL AF Registry (Real-World Evidence Registry in the Electrophysiology field).

The data demonstrated the effectiveness of the treatment in real-life situations, validating the new approach.

The innovative method will be applicable exclusively to Biosense products, including the widely used THERMOCOOL SMARTTOUCH SF catheter, among others. This advancement marks a significant leap forward in medical technology, revolutionizing the way atrial fibrillation is treated and safeguarding the health and well-being of both patients and medical professionals.

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