MINNEAPOLIS--(BUSINESS WIRE)--Cardialen, Inc., has been awarded a $2.8 million National Institutes of Health (NIH) Phase II SBIR grant to further the clinical study of Cardialen’s innovative, low-energy cardioversion of atrial fibrillation (AF) in human subjects in the United States. The grant was awarded after an expert panel of cardiologists, scientists, and engineers gave the Cardialen therapy an exceptional peer review as part of a highly competitive grant process.
Dr. John Hummel, a leading clinical researcher at The Ohio State University Wexner Medical Center specializing in the treatment of atrial fibrillation, is the principal investigator (PI) of this NIH-funded, multi-center clinical study. “Atrial fibrillation remains a serious arrhythmia, and additional treatment options are needed,” said Dr. Hummel. “The early positive results from Cardialen’s acute clinical study are very promising. I am pleased to be the PI for this important study, which is designed to evaluate therapeutic safety and efficacy in an acute clinical setting.”
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.1 Approximately 26% of ICD patients2 and 36% of CRT-D patients3 receiving an implantable cardiac defibrillator have, or will likely experience, atrial fibrillation. Cardialen seeks to provide a therapy for those patients already receiving an implantable defibrillator device.
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 ventricular tachycardia and ventricular fibrillation, in addition to treating atrial fibrillation. 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 used for atrial fibrillation and ventricular fibrillation. Learn more at www.cardialen.com.
CAUTION: Investigational Device. Limited by Federal (United States) law to investigational use only.
1. 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
2. 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
3. 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