SBIR Phase I:An innovative ablation device for treating atrial fibrillation

Period of Performance: 01/01/2010 - 12/31/2010

$150K

Phase 1 SBIR

Recipient Firm

Apama Medical
18729 METLER CT
Saratoga, CA 95070
Principal Investigator

Abstract

This Small Business Innovative Research (SBIR) Phase I Project will develop a novel balloon-based radio freqyency (RF) ablation catheter for atrial fibrillation treatment. Atrial fibrillation is the most common heart rhythm disturbance encountered in clinical medicine, accounting for 1/3 of hospital admissions for cardiac rhythm disturbances. Atrial fibrillation is frequently treated with catheter-based ablation; however, established RF methods are done via point to point manipulation using single electrode tip catheters. As a result, this technique is complex and time-consuming, requiring highly skilled physicians. Newer approaches include multi-electrode RF catheters, which have shown to create undesirable clot formations. Furthermore, mapping of the electrical activity in target tissues often requires the placement of multiple catheters in the left atrium, use of a 3D-mapping, and/or steering system. Current technologies have failed to overcome these limitations or have limited efficacy and/or safety. This project will develop a novel device that avoids these problems with an ablation balloon catheter that combines the conformability advantage of balloon-based approaches with simplicity and versatility of multi-electrode approaches. The device's utility will be validated in animal trials.