February 24, 2012 — CardioFocus Inc., developer of the HeartLight Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announced the first patient has been enrolled and treated in the HeartLight EAS U.S. pivotal trial, designed to evaluate the safety and efficacy of the technology in treating symptomatic AF.
The 48-year-old patient, one of nearly three million Americans with AF, had suffered from paroxysmal AF for three years and underwent successful pulmonary vein (PV) isolation at Mount Sinai School of Medicine in New York. All four PVs were isolated on the very first attempt using only visual guidance during the approximately two-hour procedure.
The HeartLight EAS is the first catheter ablation system to incorporate an endoscope for direct visualization of a beating heart, in real time and without radiation. It includes a compliant, dynamically adjustable balloon catheter designed for improved contact with the PV ostium irrespective of individual patient anatomy, and utilizes laser energy for more efficient, durable and precise ablation. The U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval for HeartLight EAS in December 2011, enabling the initiation of the trial.
“The visually-guided HeartLight EAS is unique in cardiac catheter ablation and offers a promising new treatment option for drug-refractory AF. For the first time, physicians can see within a beating heart to more precisely deliver ablation energy and confirm contiguous lesion placement, which we believe may lead to improved patient outcomes,” said Vivek Y. Reddy, M.D., of Mount Sinai School of Medicine, and principal investigator of the trial. “The system has been used with great clinical success in Europe, with recent published data supporting the high rate of both acute and durable PV isolation enabled by the device. We are optimistic that we will be able to achieve similar results in this trial.”
The prospective trial will randomize the HeartLight EAS against the NaviStar ThermoCool Catheter (Biosense Webster). Only a single ablation procedure with the HeartLight EAS will be permitted, while repeat ablation may be performed with the ThermoCool system. In total, the trial will randomize an estimated 350 patients at up to 25 sites in the United States and follow them for one year post-procedure.
The primary outcome measures will assess both safety and freedom from documented, symptomatic AF. The results will be used as the basis for CardioFocus’s premarket approval (PMA) filing with the FDA for HeartLight EAS. In addition to Mount Sinai, Texas Cardiac Arrhythmia Research Foundation in Austin, Texas, is also currently enrolling patients.
For more information: www.CardioFocus.com