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2026 LineupMAT-2680467 v1.0 | Item approved for U.S. use only.
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STRUCTURAL INTERVENTIONS

Amplatzer™ Paraclose PVL Occluder

Precision by design. Confidence in closure. The first and only transcatheter-based occlusion device indicated and clinically proven for paravalvular leak (PVL) closure.

STRUCTURAL INTERVENTIONS

Amplatzer™ Paraclose PVL Occluder

Precision by design. Confidence in closure. The first and only transcatheter-based occlusion device indicated and clinically proven for paravalvular leak (PVL) closure.

The Amplazter™ Paraclose PVL Occluder is designed for the unique challenges of PVL closure in a less-invasive, transcatheter procedure for hemodynamically significant PVL in patients with mechanical or bioprosthetic heart valves. Conforming to oblong and crescent-shaped defects, it enables effective closure across diverse PVL anatomies.

A solution to a key issue

Around the world, PVL are a common and challenging problem, occurring in 7% to 17% of mitral valve replacements (MVR) and 2% to 10% of aortic valve replacements (AVR). Risk factors for PVL development include: annular calcification, tissue friability, prior endocarditis, or other inflammatory processes, and recent initiation of corticosteroid therapy. PVL can occur soon after valve replacement or several years later.

By providing an effective solution to this key issue, the Amplatzer™ Paraclose PVL Occluder is improving quality of life for an increasing number of patients.

Engineered for predictable placement and procedural confidence

Every feature is designed with the procedure in mind—supporting effective closure, streamlined device selection, confident deployment with controlled delivery, clear visualization, and secure positioning. In procedures that can be technically challenging, predictability matters.

See the latest clinical data for PARADIGM Trial

Clinical Trial

Abbott Amplatzer Portfolio App helps physicians determine which structural intervention device to use


GET THE AMPLATZER PORTFOLIO APP

The Amplatzer Portfolio App helps physicians determine which Amplatzer Structural Interventions device to use by suggesting applicable devices based on respective Instructions for Use.
 

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MAT-2680111 v1.0 | Item approved for U.S. use only.

References
  1. The PARADIGM study. Data on file at Abbott.
Important Safety Information
  • Amplatzer™ Paraclose PVL Occluder

  • Rx Only

    Amplatzer™ Paraclose PVL Occluder

    INDICATIONS FOR USE

    The Amplatzer™ Paraclose PVL Occluder is indicated for use in patients who have developed a clinically significant paravalvular leak associated with a surgical aortic or mitral valve prosthesis.
     

    CONTRAINDICATIONS

    The Amplatzer™ Paraclose PVL Occluder is contraindicated for:

    • Patients with active endocarditis or other systemic infections requiring treatment
    • Patients with a rocking valve or with an extensive paravalvular leak involving more than half of the valve perimeter
    • Patients with intracardiac mass, vegetation, tumor, or thrombus at any site that may interfere with the implant procedure
    • Patients’ access site is inadequate to accommodate the appropriate sheath size
    • Patients in whom the short axis of the paravalvular leak defect exceeds 5 mm

    POTENTIAL ADVERSE EVENTS

    Acute kidney injury, Acute myocardial infarction, Air embolism, Allergic reaction/toxic effect due to contrast media, medication, or metal, Aortic dissection, Arrhythmia, Atrioventricular block, Bleeding, Cardiac perforation, Complications due to transseptal crossing, such as longer procedure times, Conversion to emergency surgery or need for later reoperation, Coronary injury, Coronary obstruction, Death, Device dislodgement, Device embolization, Device migration, Device or valve thrombosis, Endocarditis, Fracture or blockage of mechanical heart valve causing acute massive regurgitation or obstruction to blood flow, Heart failure, Hematoma, Hemothorax, Impaired hemodynamics, Infection, Interference with valve function (including bioprosthetic leaflet injury), Mechanical leaflet escape, Need for transfusion, New or worsening hemolytic anemia, Pericardial effusion, Pneumothorax, Pseudoaneurysm, Pulmonary edema, Residual, recurrent (or both) regurgitation due to procedural failure, Stroke, including transient ischemic attack, Tamponade, Thrombus, Valve dehiscence or prolapse, Vascular access-site and access-related complications, Ventricular arrhythmia

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