The FDA has granted marketing approval for the Thermocool Smarttouch ablation catheter for use in sufferers with drug-resistant paroxysmal atrial fibrillation (AF), sustained monomorphic ischemic ventricular tachycardia and Type I atrial flutter. The device is manufactured by Biosense Webster, a Johnson & Johnson Johnson & Johnson firm.
The device, according to the organization, “is the very first therapeutic catheter approved in the U.S. that permits direct and real-time measurement of make contact with force in the course of catheter ablation procedures.”
The new catheter was evaluated in the SMART-AF Trial, which was presented final May possibly at the Heart Rhythm Society meeting (webcast of presentation). At one year there was a 74% all round good results charge in patients treated with the catheter. There were, nonetheless, 4 cases of tamponade among the 160 sufferers who underwent ablation.
“The Thermcool Smarttouch catheter is an important new device that will benefit the electrophysiology neighborhood, as it will enable us to much more precisely handle the amount of make contact with force applied to the heart wall when generating lesions in the course of catheter ablation,” explained Andrea Natale, the Main Investigator of the trial, in a press release. “Data from the Intelligent-AF Trial demonstrated that consistent and stable application of get in touch with force has a important affect on patient outcomes. The use of make contact with force-sensing technological innovation has emerged as a vital instrument in delivering optimal outcomes in the therapy of individuals with atrial fibrillation and represents a significant advancement for the clinical community.”
Other manufacturers of RF ablation devices for AF include Medtronic Medtronic, Boston Scientific Boston Scientific, and St. Jude Medical.
FDA Approves New Catheter For Treatment Of Atrial Fibrillation
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