AN INNOVATIVE SOLUTION DESIGNED TO PROVIDE
A MORE GENTLE WAY TO RESTORE NORMAL HEART RHYTHM
Cardialen is developing low-energy implantable defibrillation therapy designed to more gently restore the heart to a normal rhythm.
The innovative therapy is called unpinning termination (UPT) therapy and it's designed to deliver a sequence of low-energy electrical pulses timed to disrupt the ongoing arrhythmic cardiac cycle.
Existing high-energy defibrillators can cause negative side-effects for the patient, including tissue damage and scarring. And while attempts to treat AF with current implantable defibrillators has been successful, the painful shocks are nearly intolerable for most patients.1 Recent studies indicate high-energy VF therapies may lead to increased mortality compared to patients receiving fewer shocks or a low-energy therapy.2,3 UPT therapy is being developed to treat fibrillations while reducing these negative effects.
Early human feasibility study data suggests that it may successfully treat heart rhythm disorders with substantially lower-energy therapy than is needed by existing defibrillators.4,5
- • FDA-approved IDE clinical study underway. Termination Therapy for Ventricular Tachyarrhythmias (JUPITER).
Ultimately, Cardialen's UPT therapy is designed to provide a more gentle, low-energy alternative to restoring normal heart rhythm to those affected by tachyarrhythmias.
* Limited intra-operative testing
CAUTION: Investigational Device. Limited by Federal (United States) law to investigational use only.
Geller, J., Reek, S., Timmermans, C., et al. (2003). Treatment of atrial fibrillation with an implantable atrial defibrillator – long term results. Eur Heart J, 24, 2083-2089. doi:10.1016/j.ehj.2003.09.033.
Moss AJ, Schuger C, Beck CA, et al. (2012). Reduction in Inappropriate Therapy and Mortality through ICD Programming. N Engl J Med. 367(24), 2275-83. doi:10.1056/NEJMoa1211107.
Ruwald AC, Schuger C, Moss AJ, et. al. (2014). Mortality Reduction in Relation to Implantable Cardioverter Defibrillator Programming in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT). Circ Arrhythm Electrophysiol. 7:785-792. doi:10.1161/CIRCEP.114.001623.
Ng, F-S. et. al. Painless Atrial Cardioversion using Low-Energy Multistage Electrotherapy: First-in-Man Feasibility Trial; Fu Siong Ng; 2017 Heart Rhythm Society Abstract (C-PO01-21) Heart Rhythm, 2017,14 (5):S103 (Abstr).
Meyers, J, et. al. Low Energy Multistage Electrotherapy for Ventricular Defibrillation in a Canine Model C-PO05-34 Heart Rhythm, 2017,14 (5):S432 (Abstr).