FDA approves Abbott’s new Amplatzer occluder for paravalvular leaks

Abbott (NYSE: ABT) has secured an FDA approval for a minimally invasive system to plug new leaks in a replacement heart valve, without requiring the patient to undergo open surgery a second time.

The Amplatzer Paraclose occluder is designed to address paravalvular leaks, or PVLs, which occur when blood flows backwards through small gaps between the outer edges of the implant and cardiac tissue.

According to the company, this can develop in 7% to 17% of surgical mitral valve replacements, and 5% to 10% of aortic valve replacements. 

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