AtriCure receives conditional FDA approval for heart procedure trial

AtriCure, a West Chester-based medical device company, has received conditional approval from the FDA to test a procedure to treat patients with persistent and long-standing persistent atrial fibrillation (an abnormal heart rhythm).

"Patients with persistent and long-standing persistent AF represent a large and growing number of the AF population. These patients are often the most challenging and time consuming to effectively treat," said Andrea Natale, M.D., Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David's Medical Center in Austin, Texas.

A clinical trial of the dual epicardial/ endocardial procedure (DEEP), or hybrid procedure, will occur at five U.S. medical centers on up to 30 patients. Enrollment should start later this year. The (DEEP) procedure combines surgical and catheter ablation techniques to treat patients with persistent forms of atrial fibrillation.  The trial will use AtriCure's minimally invasive surgical ablation product platform in conjunction with the Biosense Webster(R) THERMOCOOL(R) catheter ablation product platform, according to the company.

"We believe the clinical science will demonstrate that our DEEP AF hybrid procedure is an important advancement, and that stand alone minimally invasive and hybrid procedures will become a standard of care for persistent AF patients and patients that have failed catheter ablation procedures," said David J. Drachman, President and Chief Executive Officer.

AtriCure develops, manufactures and sells innovative cardiac surgical ablation systems designed to be highly precise.

Writer: Feoshia Henderson
Source: AtriCure

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