(AOF) – Affluent Medical announced today that it has filed the 510(k) pre-file for its Kalios mitral ring with the US Food and Drug Administration (FDA). The medtech recalls that a 510(k) is a pre-market submission made to demonstrate that the device in question is as safe and effective – that is to say substantially equivalent – as another comparable device already marketed. In September 2023, it published the positive clinical results of a pivotal study concerning Kalios.
The pre-submission process is a strategic step to gather FDA feedback to improve the quality of subsequent submissions, shorten review time, and facilitate the device development process.
At the end of the first quarter of 2024, Affluent Medical will host a meeting with the FDA to discuss their comments on the pre-submission package.
Affluent Medical has decided to focus its resources on the US market, which is the largest market for medtech in the world. It aims to recruit commercial partners mainly located in the United States
Kalios wants to treat mitral valve regurgitation of the heart, a serious and potentially fatal disease that affects 2% of the world’s population, or around 160 million people. Affluent Medical estimates that its product could avoid additional interventions for potentially 30 to 40% of affected patients over five years.
The first mitral annuloplasty device, Kalios is expected to be the first medtech medical device to be commercialized.
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