There are two main problems with the current therapy for postoperative atrial fibrillation (POAF):
1) IV and oral administration of antiarrhythmic drugs creates unwanted systemic side effects because high concentrations of the drugs need to be taken in order to achieve sufficient therapeutic levels within the heart tissue. In addition, these drugs take time to work and they have a high failure rate.
2) External defibrillation (cardioversion) requires additional manpower in the form of an anesthesiologist. The high amount of energy needed to place a patient back into normal sinus rhythm requires costly anesthetic drugs for sedation and can cause external skin damage, pain, and potentially life-threatening ventricular arrhythmias.
The drawbacks associated with current treatment methods inspired Native Cardio, Inc. to address an unmet need and develop a NEW method and a NEW device that can provide BOTH an effective method to deliver lower doses of antiarrhythmic drugs AND low-energy cardioversion for the treatment of POAF.
The Native Cardio Targeted Tissue Delivery System administers much lower drug doses, in some instances 100X less than current standard practices. The lower dose may alleviate or remove the unwanted systemic side effects associated with these drugs.
Unlike external cardioversion techniques, the Native Cardio Targeted Tissue Delivery System administers ultralow-energy electrocardioversion to restore normal sinus rhythm. This eliminates the need for sedation, an anesthesiologist, and it may reduce pain felt by the patient. The Native Cardio Targeted Tissue Delivery System incorporates both of these new techniques in order to address the complications associated with POAF, while addressing the needs of the various stakeholders and creating a "win-win" solution.