US-based Boston Biomedical Associates (BBA) has entered into partnership with CardioFocus, to help them in securing premarket approval (PMA) from the US Food and Drug Administration (FDA) for its HeartLight Endoscopic Ablation System designed to treat patients with paroxysmal atrial fibrillation (AF).
AF is the most common form of cardiac arrhythmia, affecting more than 33 million people globally, and an estimated 2.7-6.1 million people in the US.
The HeartLight System is said to be the first catheter ablation system that enables the electrophysiologist to monitor the delivery of therapeutic laser energy, for the first time under direct visual guidance, to electrically and durably isolate the pulmonary veins (PVs).
It features a compliant balloon catheter designed to facilitate flexibility during the procedure and is compatible to a range of PV ostiums (openings) irrespective of individual patient anatomy, and a laser energy source for more efficient and precise ablation.
The HeartLight system accounts for wide usage for the treatment of paroxysmal AF at centres throughout Europe, administered to more than 3400 patients across the world.
BBA consulting services principal Michelle Michela said: "The creativity applied to address the complexities in the approval process and to develop a clinical study report that resulted in the PMA approval in this short time span was truly impressive."
After securing the PMA approval, CardioFocus will emerge as one of the manufacturers possessing a specific indication for catheter ablation therapy of paroxysmal AF and will seek to commercialise the HeartLight System in the US.
Image: Rhythm tracing in atrial fibrillation and a drawing of a heart. Photo: courtesy of BruceBlaus.