SBIR-STTR Award

Atrial Fibrillation is an electrical malfunction of the upper pumping chambers of the heart causing major medical and lifestyle problems. The current treatments are pharmaceutical (side effects and minimal effectiveness), pacemakers (after destroying the electrical system of the heart, expensive and moderately effective), and electrically isolating areas of the heart using the MAZE procedure - surgically cutting the heart and sewing back together creating scar tissue to block malfunctioning electrical pathways. This MAZE procedure has proven to be nearly 100 percent effective, however it is long and extraordinarily difficult. Due to the promising concept, this approach is aggressively being investigated using ablation catheters and probes to create lesions. However, to isolate electrical pathways, a complete electrical block in the tissue must be made and these technologies are limited in their ability to create transmural lesions. With these technologies, charring and extensive atrial damage occur, which can increase risk of stroke. Our technology addresses these issues by incorporating RF Bipolar energy into a device that will quickly and safely create a transmural linear lesion, from endocardium to epicardium, in a single application while protecting the surrounding tissue. In Phase I we will fabricate a prototype and evaluate our lesions for transmurally and ability to electrically isolate tissue. PROPOSED COMMERCIAL APPLICATION: Our technclogy will overcome the limitations of the current methods of treating atrial fibrillation (AF) and can be used to treat AF during open-heart procedures and to reduce the occurrence of post-operative AF episodes. This market alone exceeds $1.2 BB/year. The devices that can be developed using this technology have a strong potential of being incorporated into minimally invasive procedures adding an additional $1.5 BB to the market potential.

Atrial Fibrillation is an electrical malfunction of the upper pumping chambers of the heart causing major medical and lifestyle problems. The current treatments are pharmaceutical (side effects and minimal effectiveness), pacemakers (after destroying the electrical system of the heart, expensive and moderately effective), and electrically isolating areas of the heart using the MAZE procedure - surgically cutting the heart and sewing back together creating scar tissue to block malfunctioning electrical pathways. This MAZE procedure has proven to be nearly 100 percent effective, however it is long and extraordinarily difficult. Due to the promising concept, this approach is aggressively being investigated using ablation catheters and probes to create lesions. However, to isolate electrical pathways, a complete electrical block in the tissue must be made and these technologies are limited in their ability to create transmural lesions. With these technologies, charring and extensive atrial damage occur, which can increase risk of stroke. Our technology addresses these issues by incorporating RF Bipolar energy into a device that will quickly and safely create a transmural linear lesion, from endocardium to epicardium, in a single application while protecting the surrounding tissue. In Phase I we will fabricate a prototype and evaluate our lesions for transmurally and ability to electrically isolate tissue. PROPOSED COMMERCIAL APPLICATION: Our technclogy will overcome the limitations of the current methods of treating atrial fibrillation (AF) and can be used to treat AF during open-heart procedures and to reduce the occurrence of post-operative AF episodes. This market alone exceeds $1.2 BB/year. The devices that can be developed using this technology have a strong potential of being incorporated into minimally invasive procedures adding an additional $1.5 BB to the market potential.

Thesaurus Terms:
atrial fibrillation, biomedical equipment development, heart catheterization, heart electrical activity, technology /technique development blood coagulation, electrical impedance bioengineering /biomedical engineering, sheep