Wire · opportunities
Abbott receives FDA approval for first and only device in the U.S. to treat leaks after heart ...
◆ Sectors
◆ Geography
◆ Source
◆ Verified
Fusion42 · 28 October 2026 · Fusion42 review
Abbott received FDA approval for the Amplatzer Paraclose PVL Occluder, the first minimally invasive device in the U.S. designed to treat paravalvular leak (PVL) post-heart valve replacement without requiring additional surgery, supported by clinical data from the PARADIGM study demonstrating safety and effectiveness.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
You can now bring minimally invasive solutions for heart valve leaks to US patients using an FDA-approved device that avoids repeat surgery. This clears the way to focus on marketing and clinician adoption in cardiovascular care.
◆ Coverage
1 source · 28 Oct 2026
◆ Related on Wire
◆ Topics