HEARTLANDER SURGICAL, INC. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

Project Summary Ventricular Tachycardia VT is a major public health problem associated with the majority of the cases of sudden cardiac death in the United States each year The best current therapy for VT involves drugs to reduce VT episodes plus implantation of a cardiac defibrilator ICD that prolongs life by terminating episodes of VT Permanent cessation of VT can be achieved by ablation of the origin site s and exit pathway s of the arrhythmia Despite the advantages of this technique its adoption has been limited because it is currently appropriate only for the few patients with hemodynamically stable VT This project will create a disruptive less expensive more effective and safer system for minimally invasive identification and ablation of critical VT sites It will combine the HeartLander HL epicardial walker with a non invasive mapping technology and a flexible needle based radio frequency ablation technique In prior work we have demonstrated that these technologies can be integrated into a unified system and have also eliminated major technical risks of the technologies In this Fast Track SBIR application we propose to complete the integration of the technologies and then verify the efficacy of the system in a Yorkshire swine pig model of VT Upon successful completion we will be ready to advance to the clinic a simpler safer more reliable and less expensive approach to effectively treating the annual cases of ventricular tachycardia We will also have built the hardware and computation infrastructure to support additional mapping methodologies that will enable the treatment of complex multi focal arrhythmias Project Narrative Ventricular Tachycardia VT causes deaths in the United States each year but existing treatments have significant drawbacks e g implantable cardioverter defibrillators do not prevent VT but only stop the arrhythmia with a painful shock At present it is only possible permanently treat VT the origination and or reentrance of the improper electrical signal s easily and reliably for a small percentage of the VT affected population We propose to leverage prior work merge four well understood but highly innovative NIH funded technologies provide large animal proof of concept for a therapy that will expand the number of VT patients who can receive this permanent cessation technique while significantly reducing the cost and increasing the safety of VT ablation therapy and build a platform for an on going expansion of techniques to permanently treat a range of arrhythmias