Cardialen gets FDA approval for study of MultiPulse Therapy
The clinical trial will assess the performance and safety of MultiPulse Therapy in paroxysmal and persistent AF patients.
Cardialen has obtained approval from the the US Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to commence clinical trial of its MultiPulse Therapy (MPT) for the treatment of paroxysmal and persistent atrial fibrillation (AF).
The low-energy MPT 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 FDA 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 Ohio State University Wexner Medical 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 MPT 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.