13 Apr Boston Biomedical Associates Partners with CardioFocus in Premarket Approval of HeartLight System
Marlborough, MA – Boston Biomedical Associates (BBA) partnered with CardioFocus to assist them in successfully receiving premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its HeartLight Endoscopic Ablation System for the treatment of patients with paroxysmal atrial fibrillation (AF).
“We are pleased to have assisted CardioFocus in this significant project through a collaborative effort that enabled them to complete the PMA submission and approval from the FDA in just eight months,” noted BBA President Lauren Baker, PhD. BBA’s involvement focused on strategic statistical approaches to trial design, data presentation and subsequent statistical analysis. “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,” said Michelle Michela, MS, principal of Consulting Services at BBA.
With the granting of PMA approval, CardioFocus becomes one of few manufacturers possessing a specific indication for catheter ablation therapy of paroxysmal AF. The U.S. pivotal clinical study results are added to dozens of independent studies supporting the CardioFocus HeartLight System. To date, more than 3,400 patients worldwide have been treated using the CardioFocus HeartLight system. CardioFocus is finalizing plans to commercialize the HeartLight System in the United States.