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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 Clinical Data

The Amplatzer™ Paraclose PVL Occluder is designed for the unique challenges of PVL closure. It is a less-invasive, transcatheter procedure for hemodynamically significant PVL in patients with mechanical or tissue heart valves and enables effective closure across diverse PVL anatomies.

STRUCTURAL INTERVENTIONS

Amplatzer™ Paraclose PVL Occluder Clinical Data

The Amplatzer™ Paraclose PVL Occluder is designed for the unique challenges of PVL closure. It is a less-invasive, transcatheter procedure for hemodynamically significant PVL in patients with mechanical or tissue heart valves and enables effective closure across diverse PVL anatomies.

PARADIGM study

The PARADIGM study is a prospective, multicenter, international single-arm study that evaluated the safety and effectiveness of the Amplatzer™ Paraclose PVL Occluder and is the first prospective PVL occluder study supporting indication approval.

Participants must have been implanted with a surgical mechanical or biological valve in the aortic or mitral position and have developed a clinically significant paravalvular leak, with a severity grade of moderate or higher, associated with signs of heart failure and hemolysis necessitating recuring blood transfusions.

Design Overview


200
patients enrolled


24
medical sights globally

Implant success1*

 

Freedom from intraprocedural death1
 

Freedom from device related surgical procedures or reintervention1

Reduction in PVL by greater than or equal to two grades1
 

Supporting confidence in both deployment and patient outcomes, success measures show:

PVL severity grade reduction

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.
 

App Store
Google Play

MAT-2680110 v1.0 | Item approved for U.S. use only.

References
  1. ARTEN600369435_Amplatzer Paraclose IFU.
Important Safety Information

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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