Study Begins for Phoenix Cardiac's BACE Mitral Device

January 14, 2013—Phoenix Cardiac Devices, Inc. (Northbrook, IL) announced that the first patient has been enrolled in a clinical trial that will assess the safety and efficacy of the company’s BACE device, which is an adjustable tension band that encircles the heart and supports the mitral valve leaflets in patients with mitral regurgitation. The trial will be used to gain CE Mark approval in Europe. The product name derives from the acronym BACE (Basal Annuloplasty of the Cardia Externally).

As stated in company’s press release, previous studies of BACE, including a proof-of-concept study in 12 patients and a feasibility study in 14 patients, demonstrated a significant reduction in mitral regurgitation and no device-related serious adverse events after implantation. Results of the proof-of-concept study were published in the Australian journal, Heart, Lung and Circulation in December 2009.

The current study will enroll 60 patients in India and Europe, who have moderate-to-severe functional mitral regurgitation. Patients will undergo implantation of the BACE device, which is designed to prevent many of the complications that occur with traditional surgical repair of mitral valves.

According to the Phoenix Cardiac Devices, the BACE device was developed to provide a more effective and less invasive method of treating mitral regurgitation that reduces complications and thus lowers the risk of mortality. The company noted that as a closed heart procedure, implantation of the BACE device may also reduce operating times and hospital stays, resulting in significantly lower costs than with open heart procedures. Among its features, BACE can be remotely adjusted from an external port, and its efficacy can be assessed through real-time echocardiography, allowing for immediate adjustments in tension and pressure. The BACE device was invented by Jai Raman, MD, Professor of Surgery, Director of Adult Cardiac Surgery, and Surgical Director of Transplantation at Rush University Medical Center in Chicago.