CardioFocus will complete full patient enrollment in a US pivotal clinical trial of its HeartLight catheter ablation system in 2013.
The 350 patient-based trial, which is evaluating and comparing the safety and efficacy of the company’s HeartLight catheter ablation system with the NaviStar Thermocool catheter (Biosense Webster) for treating atrial fibrillation (AF), has currently enrolled over 180 patients, according to the company.
The CE marked HeartLight system features an endoscope for direct visualization of the beating heart, a laser energy source and a compliant balloon catheter.
Mt Sinai University Medical Center electrophysiology laboratories director and trial co-principal investigator Vivek Reddy said a key challenge in the treatment of AF has been the durability of the intervention.
"In this trial, we are investigating whether the unique attributes of the HeartLight technology can impact both acute and chronic freedom from AF, and offer a new option for treating this complex condition," Reddy added.
CardioFocus regulatory and clinical affairs vice president Burke Barrett said achieving the enrollment milestone speaks to the clinical need for an advanced treatment for AF.
"We are excited that so many prominent physicians across the country have joined the trial as investigators and believe in the promise of the technology for their patients," Barrett added.
"We’re on track to conclude enrollment in 2013 and, after the one year follow-up period, will prepare the data for submission to the FDA."