Medtronic, Inc. has the FDA’s approval to initiate the Feasibility of the Lone Atrial Fibrillation Clinical Trial (FACT), which coincides with the launch of Medtronic’s Cardioblate Navigator Tissue Dissector.
The purpose of the FACT feasibility clinical trial is to evaluate the use of the Cardioblate Surgical Ablation System thorascopically in paroxysmal atrial fibrillation patients. The prospective, non-randomized, feasibility clinical trial will enroll 15 patients at three U.S. medical centers including Scott & White Memorial Hospital (Temple, TX), Beth Israel Hospital (Boston, MA), and LDS Hospital (Salt Lake City, UT). The primary endpoints of the trial are to evaluate the freedom of symptomatic paroxysmal AF episodes using Cardioblate surgical ablation devices in lone AF patients.
While none of the devices used in the trial are investigational, results of the trial will be used to design U.S. pivotal studies for an additional indication of use for the Cardioblate Surgical Ablation System in the U.S. to treat paroxysmal atrial fibrillation. The commercial release of the Navigator Tissue Dissector complements Medtronic’s Cardioblate family of bipolar solutions with technology for this stand-alone, surgical ablation procedure.
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