CardioFocus said today that the FDA accepted its pre-market approval application for the HeartLight visually-guided laser balloon ablation device for treating atrial fibrillation.
The PMA bid, backed by data from a 353-patient pivotal study in which subjects were randomly assigned to treatment with either the laser balloon or standard radiofrequency ablation. The results, presented last May at the annual Heart Rhythm Society meeting in Boston, showed similar safety and efficacy results for the HeartLight arm as the standard RF ablation cohort.
Announcing the results at HRS 2015, principal investigator Dr. Vivek Reddy of new York’s Mt. Sinai Hospital said that although treatment times were much higher for the HeartLight arm, that was most likely due to the novelty of the device.
“I was pleased. On 1 hand, I’d love to see the laser work better than point-by-point ablation; on the other hand, the majority of these operators have never touched this device and were expected to perform as well as a technology they’ve used hundreds of times,” Reddy said at the time. “One important point is you have to remember the physicians that performed the RF ablation procedures had a lot of experience with RF ablation. Each of them had performed hundreds, if not thousands, of RF ablations. In contrast, the physicians in the study had relatively little experience using the laser balloon. Even at the conclusion of the study they had relatively little experience – none of the operators had performed more than 15 procedures. Despite that, again, there was similar efficacy. Why does that matter? If we look at European experience where this device has been approved, just as with the cryoballoon, you have improvements in efficacy, you have improvements in safety.”
Expanded results published this month in the Journal of the American College of Cardiology bore that out, with increased operator experience resulting in significant improvements in time under fluoroscopy and non-significant improvements in procedure time, efficacy and safety, the researchers wrote.
“Publication of these data from our U.S. pivotal trial of HeartLight in the JACC, 1 of the most prestigious and well-read cardiology peer-reviewed journals, not only provides us with comprehensive verification of the quality and thoroughness of our trial but also serves as tremendous validation by the medical community of the clinical outcomes showing HeartLight met both primary efficacy and safety endpoints and demonstrated a low learning curve for physicians. Equally, we are very excited to have our PMA application accepted for review by the FDA and look forward to providing an update on anticipated timing for FDA response regarding potential approval,” president Stephen Sagon said in prepared remarks.