Cardialen has obtained approval from the the US F ood and Drug Administration (F DA) for an Investigational Device Exemption (IDE) to commence clinical trial of its M ultiPulse Therapy (M PT) for the treatment of paroxysmal and persistent atrial fibrillation (AF ).
The low-energy M PT is intended to use the latest implantable device technologies to treat tachycardia and fibrillation.
It is provided as a sequence of low-energy electrical pulses to return irregular rapid heartbeats, such as AF , to a normal rate.
The company believes that this method of electrical pulse delivery will potentially be less painful for the patient.
Cardialen said that this trial builds on its previous study as well as a companion study that is currently enrolling participants across seven medical centres in Australia.
The M edical Center” target=”_blank”>Ohio State University Wexner M edical Center lead clinical researcher, and principal investigator of the study, Dr John Hummel said: “We are excited to be contributing to Cardialen’s ongoing development of this AF therapy.
AF is an irregular and rapid heartbeat that can lead to discomfort, risk of stroke and other heart-related complications in patients.
According to Cardialen, about 36% of CRT-D patients and 26% of implantable cardioverter defibrillator (ICD) patients have, or are expected to experience, AF .