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.”