Cardialen Announces Positive Results from Low-Voltage MultiPulse Therapy to Terminate Atrial Fibrillation

• MultiPulse Therapy™ (MPT™) achieved 71% termination of acute, induced atrial fibrillation (AF) episodes at energy levels deemed to be tolerable for patients^1,2

MINNEAPOLIS--(BUSINESS WIRE)--Cardialen, Inc., has published a first-in-human study in the Journal of the American College of Cardiology: Clinical Electrophysiology titled Novel Low-Voltage MultiPulse Therapy to Terminate Atrial Fibrillation. The study consisted of 42 patients who were indicated for AF ablation. In the efficacy portion of the study, MPT achieved 71% termination of AF episodes at energy levels deemed to be tolerable for patients (interquartile range of 0.14 to 1.21 Joules).

Dr. Fu Siong Ng, a leading clinical researcher at the National Heart & Lung Institute, Imperial College London, United Kingdom, stated: “Cardialen’s MPT therapy effectively terminated atrial fibrillation at energies known to be tolerated by patients. This therapy shows promise for treating AF in patients receiving an implantable defibrillator who may have or also develop AF.”

Atrial fibrillation is an irregular and rapid heart rate that can lead to patient discomfort and increased risk of stroke. Approximately 34 million patients suffer from this condition worldwide.³ Approximately 26% of implantable cardioverter defibrillator (ICD) patients,⁴ and 36% of cardiac resynchronization therapy defibrillator (CRT-D) patients,⁵ receiving an implantable cardiac defibrillator have, or will likely experience, atrial fibrillation. Cardialen seeks to develop a therapy for those patients already receiving an implantable CRT-D device.

About Cardialen

Cardialen, Inc. is a Minneapolis-based medical device company developing implantable, low-energy defibrillation and cardioversion therapy designed to treat dangerously fast heart rhythms, including atrial fibrillation and ventricular tachycardia. Cardialen’s MultiPulse Therapy™ (MPT™) uses a patented sequence of low-energy pulses to restore normal heart rhythm more gently than high-energy, often painful, shocks currently used to treat cardiac arrhythmias. Learn more at www.cardialen.com.

CAUTION: Investigational Device. Limited by Federal (United States) law to investigational use only.

References:

1. Ladwig, K.-H. et al. Absence of an impact of emotional distress on the perception of intracardiac shock discharges. Int. J. Behav. Med. 10, 56–65 (2003).
2. Murgatroyd, F. D. et al. Efficacy and tolerability of transvenous low energy cardioversion of paroxysmal atrial fibrillation in humans. J. Am. Coll. Cardiol. 25, 1347–53 (1995).
3. Chugh SS, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: A global burden of disease 2010 study. Circulation. 2014;129(8):837-847. doi:10.1161/CIRCULATIONAHA.113.005119
4. Mustafa U, Dherange P, Reddy R, et al. Atrial Fibrillation Is Associated With Higher Overall Mortality in Patients With Implantable Cardioverter‐Defibrillator: A Systematic Review and Meta‐Analysis. J Am Heart Assoc. 2018;7(22). doi:10.1161/JAHA.118.010156
5. Mustafa U, Atkins J, Mina G, et al. Outcomes of cardiac resynchronisation therapy in patients with heart failure with atrial fibrillation: A systematic review and meta-analysis of observational studies. Open Hear. 2019;6(1):1-12. doi:10.1136/openhrt-2018-000937