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April 29, 2021updated 22 Apr 2022 5:56am

CE mark awarded to Phoenix Cardiac Devices’ BACE system

On April 28, 2021, Phoenix Cardiac Devices gained regulatory CE mark approval for its BACE (basal annuloplasty of the cardiac externally) device, for treatment of functional mitral regurgitation.

By GlobalData

On April 28, 2021, Phoenix Cardiac Devices gained regulatory CE mark approval for its BACE (basal annuloplasty of the cardiac externally) device, for treatment of functional mitral regurgitation.

The BACE device is unique compared to other existing devices that treat mitral regurgitation by repairing or replacing the mitral valve. The BACE device sits outside of the heart and does not touch the bloodstream, meaning that the chance of stroke, thrombosis or infection that sometimes occur with implanted devices is largely reduced. The BACE device does not require open-heart surgery for implantation, which is a large benefit during the COVID-19 pandemic when shorter hospital stays are desired in order to make space for expected influxes of COVID-19 patients.

Devices do already exist on the market to either repair or replace the mitral valve to treat mitral regurgitation, and both of these treatments can be done either via open surgery or transcatheter means. In the transcatheter mitral valve repair market, Abbott Laboratories is the market leader with the only product approved for use in the US (the MitraClip), although other manufacturers sell devices outside of the US. GlobalData estimates that the transcatheter mitral valve repair market was worth approximately $700M globally in 2020; this value represents a decline that occurred in 2020 due to the COVID-19 pandemic.

GlobalData predicts that Phoenix Cardiac Devices will take revenue from both the transcatheter and open surgical mitral valve repair and replacement markets by addressing the treatable population in a new and unique way. As a result, the market value for other types of mitral valve repair and replacement devices will drop, while the value for this new and innovative type of device will soar.

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