The Mason, Ohio-based company’s DEEP trial is an FDA investigational device exempt study exploring the safety and efficacy of the company’s dual epicardial and endocardial procedure intended to treat persistent and long-standing persistent atrial fibrillation.
“The DEEP trial reinforces AtriCure’s commitment to continue to expand the presence in minimally invasive treatment of persistent and long-standing persistent patients and to improve the lives of these difficult to treat patients. We’ve worked very closely with the FDA and with our investigators to do everything we can to ensure a safe, effective and repeatable procedure,” prez & CEO Michael Carrel said in a press release.
The DEEP trial aims to enroll up to 220 patients, having been granted approval from the FDA to restart and add an additional 40 subjects last December. A total of 48 patients have been treated in the trial so far, with the first patient being treated by a team led by Dr. Mark La Meir and Dr. Carlo de Asmundis at Belgium’s Universitair Ziekenhuis Brussels.
“The DEEP trial brings electrophysiologists and cardiac surgeons together as a team in an effort to establish a safe and effective care pathway for patients presenting with persistent or long-standing persistent Afib. We are excited about the restart of enrollment in this important trial,” La Meir of UZ Brussels said in a prepared statement.
Last month, AtriCure saw its shares fall slightly despite the medical device maker posting fourth quarter earnings that topped expectations on Wall Street.