Cardialen gets FDA approval for study of its Multipulse Therapy for AF


Cardialen has received approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) to begin a clinical trial of its Multipulse Therapy (MPT) to treat paroxysmal and persistent atrial fibrillation (AF).

MPT is delivered as a sequence of low-energy electrical pulses designed to restore abnormally rapid heart rates to a normal rhythm in a manner potentially less painful to the patient. This FDA-approved trial builds on a previous study conducted by Cardialen, as well as its companion study that is currently enrolling patients at seven medical centres in Australia.

John Hummel, a clinical researcher at The Ohio State University Wexner Medical Center (Columbus, USA) and the principal investigator of the study, said: “We are excited to be contributing to Cardialen’s ongoing development of this AF therapy. I believe MPT has the potential to improve heart failure outcomes in patients suffering from AF and receiving a CRT-D implant.”

Also commenting on the IDE approval, Igor Efimov, Cardialen founder, said: “I am pleased with Cardialen’s progress. This will build on the approximately 100 patients already treated. MPT has the potential to offer patients an option of pain-tolerable cardioversion.”


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