In July 2019, Abbott released its fourth-generation MitraClip, a minimally invasive device used to treat severe mitral regurgitation.

Mitral regurgitation is the most prevalent of all valvular diseases, affecting almost 10% of the population ages 75 and older. Before the approval of the MitraClip in 2013, there was a large unmet need for high-risk patients who were not eligible for surgical interventions, and in particular, older patients with severe mitral regurgitation.

Abbott’s G4 FDA approval

Abbott’s MitraClip offers a percutaneous option for high-risk patients to receive treatment and is the only US Food and Drug Administration-approved transcatheter mitral valve repair (TMVR) device on the market.

Due to the potential growth and opportunities within the mitral valve repair market, GlobalData expects that other major manufacturers will soon enter the market. Edwards Lifesciences announced its six-month results in an ongoing clinical trial for its CE-marked mitral valve repair device, Pascal, in hopes to rival the MitraClip in the US market.

The Pascal received its CE mark in early 2019 but demonstrated a much slower uptake than expected in Europe, unable to disrupt Abbott’s market leader position. However, should the Pascal demonstrate superior results over the MitraClip, in combination with the company’s established reputation in the heart valves market, it is conceivable that Edwards could potentially become a threat to Abbott’s position.

The fourth-generation MitraClip includes an expanded number of clip sizes, as well as an upgraded catheter that allows for real-time pressure monitoring during implantation. GlobalData expects that Abbott will continue to dominate the TMVR market in the next five years despite the entrance of Edwards’ Pascal. Abbott’s established presence within the market as well as multiple generations of the MitraClip puts Abbott in a strong position against any upcoming competition.