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.

The latest F DA approval will allow the company to begin a clinical study to assess the therapy’s performance and safety in paroxysmal and persistent AF patients.

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.

“I believe M PT has the potential to improve heart failure outcomes in patients suffering from AF and receiving a cardiac resynchronisation therapy defibrillator (CRT-D) implant.”

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 .

In October 2018, Cardialen raised $17m funding in a series B investment round led by RiverVest Venture Partners to develop an implantable defibrillation therapy for restoring normal heart rhythm.