Phoenix Cardiac Devices recently gained regulatory CE mark approval for its basal annuloplasty of the cardiac externally (BACE) device, for treatment of functional mitral regurgitation. The company is set to shake up the mitral valve treatment markets due to its device being placed outside of the heart, which is a beneficial feature since it reduces the chances of the patient experiencing stroke, thrombosis or infection related to devices implanted into the bloodstream, says GlobalData, a leading data and analytics company.

Ashley Young, Senior Medical Devices Analyst at GlobalData, comments: “While there are a number of different devices on the market to treat mitral valve regurgitation through valve repair or replacement, the BACE device is unique since it sits outside of the heart. Compared to existing devices, it does not require open surgery to implant; this feature makes it an attractive option during the COVID-19 pandemic, when shorter hospital stays are preferred over longer ones.”

Due to the benefits of the BACE device, it is likely that patients with mitral regurgitation may be treated with this device going forward, rather than other existing devices on the market. One other option for people with mitral regurgitation is transcatheter mitral valve repair (TMVR), and there is only one TMVR device commercially available in the US: Abbott Laboratories’ MitraClip device.

GlobalData estimates the transcatheter mitral valve repair market (TMVR) to have been worth approximately $700m globally in 2020; however, this value will be negatively impacted if the BACE device is used in place of TMVR devices in patients with mitral regurgitation. The BACE device will also likely impact the markets for open surgical mitral valve repair and replacement in similar ways, since patients that would have otherwise been treated by open surgical valve replacement or repair may now be treated with the BACE device instead.