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THE TAPE

StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Boston Scientific puts the August cyberattack at $150M of lost third quarter sales Boston Scientific pushes its $14.5B Penumbra close into early 2027 GT Metabolic raises a Series C from J.P. Morgan for magnetic anastomosis Ottobock leads a $10.5M Series A in prosthetic control startup Blue Arbor Abbott wins the first US approval for a transcatheter paravalvular leak device Pharaoh Neuro takes a Breakthrough designation for filtering blood out of spinal fluid

FDA Approval

Abbott wins the first US approval for a transcatheter paravalvular leak device

MedDevice Startups Staff · 2 days ago · 2 min read · Via Abbott press release

FDA approved Abbott's Amplatzer Paraclose PVL Occluder on October 28, the first device approved in the US specifically to close paravalvular leaks after surgical valve replacement. The implant goes in through an artery or vein in the leg and sits inside the leak channel. The alternative, until now, was repeat open-heart surgery.

The approval rests on PARADIGM, a prospective, multicenter, single-arm study of 200 patients. Abbott puts paravalvular leak at 7 to 17 percent of mitral valve replacements and 5 to 10 percent of aortic replacements. The backflow can drive heart failure symptoms, and the hemolysis it causes can reach severe anemia.

The occluder has an elliptical shape meant to fit the irregular channels a leak takes. It has been on the European market since 2020 as the Amplatzer Valvular Plug III. Six years passed between that launch and this approval, and Abbott still needed a 200-patient IDE study to close the gap.

Questions & Answers

What is the Abbott Amplatzer Paraclose PVL Occluder?

The Amplatzer Paraclose PVL Occluder is a transcatheter implant from Abbott that closes paravalvular leaks around a replaced heart valve. Abbott announced FDA approval on October 28, 2026, and it is the first device approved in the US for that specific indication.

What study supported FDA approval of the Amplatzer Paraclose PVL Occluder?

Abbott's approval rests on PARADIGM, a prospective, multicenter, single-arm study of 200 patients. Abbott announced the FDA approval of the Amplatzer Paraclose PVL Occluder on October 28, 2026.

How common is paravalvular leak after heart valve replacement?

Abbott puts paravalvular leak at 7 to 17 percent of mitral valve replacements and 5 to 10 percent of aortic valve replacements. Left untreated, the backflow can cause heart failure symptoms and hemolysis severe enough to cause anemia.

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