Edwards has received approval from the Food and Drug Administration for its Sapien M3 mitral valve replacement system, the company said Tuesday.

The device is intended for people with moderate difficulty severe mitral regurgitationa heart condition in which the valve between the left chambers of the heart does not close completely, allowing blood to flow backwards. The Sapien M3 is intended for people who are considered ineligible for surgery or edge-to-edge percatheter repair therapy, a minimally invasive procedure to fix the valve by compressing its leaflets.

Edwards says his Sapien M3 device is the first transcatheter therapy using a transseptal approach approved by the FDA for the treatment of mitral regurgitation. The procedure consists of two steps: delivery of the dock, followed by delivery of the valve to completely replace the mitral valve.

The approval was confirmed by the results of a 299-person, single-arm pivotal study. According to results published in The Lancet, patients observed a significant removal mitral regurgitation and significant improvement in symptoms and quality of life.

Adding the option of valve replacement could expand the treatment to new patients not previously treated, said Daveen Chopra, Edwards’ vice president of mitral and tricuspid transcatheter therapy. analyst’s day earlier this month.

in 2022 Edwards received FDA approval for its Pascal Precision system for mitral valve repair. At the beginning of this year the company received the European CE mark For the Sapien M3 system.