The devices can now be guided with ultrasound which reduces radiation exposure to patients and medical staff.
Medical staff will no longer need to wear lead aprons when using Johnson & Johnson’s (J&J) catheter-based atrial fibrillation ablation devices, following the US Food and Drug Administration’s (FDA) approval of their use without the need for fluoroscopy.
Currently, fluoroscopy is used in a range of procedures that require imaging guidance. BioSense Webster, which manufactures the devices under J&J, says that the catheters can be guided with ultrasound instead.
Ultrasound does not expose the patient or staff to radiation, unlike fluoroscopy which requires lead aprons to be worn for radiation protection.
“Eliminating or reducing radiation exposure is beneficial to patients as well as physicians and staff working every day in the electrophysiology lab,” said Dr Jose Osorio, FHRS, president of Heart Rhythm Clinical and Research Solutions.
The updated label change, which applies to the Thermocool Smarttouch catheters, Pentaray Nav catheter, Decanav mapping catheters, Webster CS catheter, and Carti Vizigo guiding sheath, follows an observational, prospective, multicentre registry that opened in 2019. California-based BioSense Webster claims the registry is a world first in the electrophysiology field, which has been tracking the efficiency, safety, and long-term effectiveness in atrial fibrillation patients with radiofrequency technologies.
Biosense Webster’s 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.”
A market model by GlobalData forecasts the global ablation catheter market will be worth $4.2bn by 2033. Ablation procedures are estimated to total 2.6 million in 2033, with atrial fibrillation being the most numerous – contributing 1.3 million.
