Research and Development

CardiaLen’s technology is based on discoveries by Igor Efimov, PhD, currently the Lucy & Stanley Lopata Professor of Biomedical Engineering at Washington University in St. Louis, and prior to that, at Case Western Reserve University in Cleveland, Ohio. These discoveries support the theory that heterogeneities (anatomical obstacles such as scars or pulmonary veins) can serve as anchors for errant circuits and effectively “pin” or “anchor” reentry arrhythmias, thus allowing the errant circuit to stabilize. These heterogeneities serve as “virtual electrodes” and allow low-energy electric shocks to induce maximum tissue depolarization where errant circuits have stabilized.  Research teams led by Prof. Efimov have demonstrated, in in vitro and in vivo studies, that very low-voltage shock, applied in selected waveforms and multiple-pulse algorithms, induces virtual electrode polarization (VEP) at these heterogeneities, opening a new low-energy approach to defibrillation.

Such studies have recently been taken further. Most recently, acute animal trials were completed with highly satisfactory results at the Cardiothoracic Surgical Research laboratory, Washington University School of Medicine, demonstrating cardioversion of sustained AF at below currently-accepted pain thresholds. The company is now conducting chronic canine studies, allowing for extended application of the same low-energy therapy. Current acute and chronic preclinical studies use prototype leads and equipment developed specifically for CardiaLen.

CardiaLen is preparing for its First-in-Human studies, to commence in the last quarter of 2011, by having already completed its clinical protocols and development of its prototype device for such study.