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Clinical Data

BETTER EVIDENCE TO BUILD CONFIDENCE

Abbott provides a robust body of clinical evidence encompassing clinical data and outcomes from tens of thousands of patients across our structural heart portfolio of products.*

IN-DEPTH DATA ABOUT STRUCTURAL HEART PRODUCTS

With our Clinical Insights and Bulletins you can take a deeper dive into clinical outcomes related to structural heart products. Designed for ease of viewing, these pieces give you a broader perspective about study outcomes along with product safety and performance.

Transcatheter Valve Solutions

  • MITRACLIP™ FOR TEER

    Cardiovascular Physiology in Mitral Regurgitation

    Read more
  • MITRACLIP™ FOR TEER

    Hemodynamic Monitoring During MitraClip™ Procedures

    Read more

Structural Interventions

  • AMPLATZER™ AMULET™ LAA OCCLUDER

    Clinical Experience with Amplatzer™ Amulet™ Left Atrial Appendage Occluder for Reducing Risk of Ischemic Stroke in Patients with AF.

    Read more
  • AMPLATZER™ ATRIAL SEPTAL OCCLUDER

    Amplatzer™ Atrial Septal Occluder Clinical Data Update

    Read more
  • Advantages of the Intaglio wire treatment of the Amplatzer Occluders
    AMPLATZER™ INTAGLIO™ WIRE TREATMENT

    Advantages of the Intaglio™ Wire Treatment of the Amplatzer™ Occluders

    Read more

Surgical Valve Solutions

  • MASTERS SERIES MITRAL MECHANICAL HEART VALVES

    Key Mitral MHV Selection Considerations: Durability,
    Size Range, Hemodynamics, and Implantability1

    Read more
  • Epic™ Mitral Stented Tissue Valve with Linx™ AC Technology

    Long-Term Outcomes and Freedom from Calcification

    Read more
  • EPIC™ MITRAL STENTED TISSUE VALVE WITH LINX™ AC TECHNOLOGY

    Epic Mitral – Ten Year Clinical Outcomes of SMVR in a Medicare Population1

    Read more
  • Clinical studies find consistent durability in Epic Mitral Valve tested over 35 years
    EPIC™ MITRAL STENTED TISSUE VALVE WITH LINX™ AC TECHNOLOGY

    Epic™ Mitral Continues the Biocor™ Legacy: Strength of Design, Tested Over 35 Years2

    Read more
  • EPIC™ MITRAL AND EPIC™ SUPRA STENTED TISSUE VALVES

    Three-Year Outcomes of Valve-in-Valve Intervention within the Epic™ Supra and Epic™ Mitral Valves in a Medicare Population

    Read more
  • EPIC™ SUPRA AORTIC STENTED TISSUE VALVE WITH LINX™ AC TECHNOLOGY

    Ten-Year Outcomes of a Contemporary Supra-annular Porcine Aortic Bioprosthesis in a Medicare Population1

    Read more

CLINICAL DATA | STRUCTURAL INTERVENTIONS

MAT-2116292 v11.0 | Item approved for U.S. use only.

References

*Data on File at Abbott

  1. Rodriguez, E. et. al. (2022, January). Ten-Year Outcomes of a Contemporary Generation Low-Profile Porcine Mitral Bioprosthesis in a Medicare Population. Poster presented at the STS Annual Meeting, Virtual.
  2. Mykén, P. S. U., & Bech-Hansen, O. (2009). A 20-year experience of 1712 patients with the Biocor porcine bioprosthesis. The Journal of Thoracic and Cardiovascular Surgery, 137(1), 76–81. doi.org/10.1016/j.jtcvs.2008.05.068

 

Important Safety Information
  • MitraClip
  • Navitor
  • EPIC MAX
  • Epic PLUS
  • Masters Series
  • Regent
  • Amplatzer Amulet
  • Amplatzer Talisman PFO
  • Amplatzer Septal Occluder
  • Amplatzer VSD Occluders
  • Amplatzer Piccolo Occluders
  • Amplatzer Duct Occluders

  • Rx Only

    MITRACLIP DELIVERY SYSTEMS

    INDICATION FOR USE
     

    • The MitraClipTM G4 System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
    • The MitraClipTM G4 System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

    CONTRAINDICATIONS

    The MitraClip G4 System is contraindicated in patients with the following conditions: Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regime; Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity; Active endocarditis of the mitral valve; Rheumatic mitral valve disease; Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus.

    POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

    The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip G4 procedure: Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs, Vascular access complications which may require transfusion or vessel repair including: wound dehiscence, catheter site reactions, Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage), Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion, Emboli (air thrombotic material, implant, device component); Peripheral Nerve Injury; Lymphatic complications; Pericardial complications which may require additional intervention, including: Pericardial effuse on, Cardiac tamponade, Pericarditis; Cardiac complications which may require additional interventions or emergency cardiac surgery, including: Cardiac perforation, Atrial septal defect; Mitral valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single Leaflet Device Attachment (SLDA), Thrombosis, Dislodgement of previously implanted devices, Tissue damage, Mitral valve stenosis, Persistent or residual mitral regurgitation, Endocarditis; Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina); Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism); Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction / failure / atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Hypotension / hypertension; Infection including: Urinary Tract Infection (UTI), Pneumonia, Septicemia; Nausea / vomiting; Chest pain; Dyspnea; Edema; Fever or hyperthermia; Pain; Death; Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation; Esophageal perforation, Gastrointestinal bleeding.

  • Rx Only

    NAVITOR™ TRANSCATHETER AORTIC VALVE IMPLANTATION SYSTEM

    INDICATIONS

    The Navitor™ Transcatheter Aortic Valve Implantation System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).

    CONTRAINDICATIONS  

    The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.

    POTENTIAL ADVERSE EVENTS  

    Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to: access site complications (e.g., pain, bleeding, infection, hematoma, pseudoaneurysm, etc.); acute coronary obstruction; acute myocardial infarction; allergic reaction to antiplatelet agents, contrast medium, or valve components; aortic rupture; ascending aorta trauma; atrio-ventricular node block; cardiac arrhythmias; conduction system injury; conversion to open surgical procedure; death; dissection; embolism; emergent balloon valvuloplasty; emergent percutaneous coronary intervention (PCI); emergent surgery (i.e., coronary artery bypass, heart valve replacement); endocarditis; explantation; heart failure; hemodynamic compromise; hemolysis; hemolytic anemia; hemorrhage; hypotension or hypertension; infection; myocardial ischemia; mitral valve insufficiency; multi-organ failure; non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, inappropriate sizing or positioning); pannus; pericardial effusion; perforation of the myocardium, ventricle, or a blood vessel; permanent disability; permanent pacemaker; regurgitation; renal insufficiency or renal failure; reoperation; respiratory failure; sepsis; stroke; structural deterioration (i.e., calcification, leaflet tear); thrombosis; tamponade; transfusion; valve embolization or migration; vessel dissection or spasm.

  • Rx Only

    EPIC™ MAX STENTED PORCINE TISSUE VALVES
    INDICATIONS FOR USE

    The Epic™ Max valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve. 

    CONTRAINDICATIONS

    None known. 

    POTENTIAL ADVERSE EVENTS

    Adverse events potentially associated with the use of bioprosthetic heart valves (in alphabetical order) include: angina; cardiac arrhythmias; endocarditis; heart failure; hemolysis; hemolytic anemia; hemorrhage, anticoagulant/antiplatelet-related; leak, transvalvular or paravalvular; myocardial infarction; nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other); prosthesis regurgitation; stroke; structural deterioration (calcification, leaflet tear, or other); thromboembolism; valve thrombosis. It is possible that these complications could lead to: reoperation; explantation; permanent disability; death. 

  • Rx Only

    EPIC™ PLUS/EPIC™ PLUS SUPRA STENTED PORCINE TISSUE VALVES

    INDICATION FOR USE

    The Epic™ Plus valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve.

    The Epic™ Plus Supra valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve.

    CONTRAINDICATIONS

    None known.

    POTENTIAL ADVERSE EVENTS

    Adverse events potentially associated with the use of bioprosthetic heart valves (in alphabetical order) include: angina; cardiac arrhythmias; endocarditis; heart failure; hemolysis; hemolytic anemia; hemorrhage, anticoagulant/antiplatelet-related; leak, transvalvular or paravalvular; myocardial infarction; nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other); prosthesis regurgitation; stroke; structural deterioration (calcification, leaflet tear, or other); thromboembolism; valve thrombosis.

    It is possible that these complications could lead to: reoperation; explantation; permanent disability; death.

  • Rx Only

    MASTERS SERIES MECHANICAL HEART VALVE

    INDICATION FOR USE

    The SJM™ Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. This device may also be used to replace a previously implanted mitral or aortic prosthetic valve.

    CONTRAINDICATIONS

    The SJM™ Masters Series Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.

    POTENTIAL ADVERSE EVENTS

    Complications associated with replacement mechanical heart valves include, but are not limited to, hemolysis, infections, thrombus, or thromboembolism, valve dehiscence, unacceptable hemodynamic performance, hemorrhagic complications secondary to anticoagulation therapy, prosthetic failure, failure or death. Any of these complications may require reoperation or explantation of the device.

  • Rx Only

    REGENT™ MECHANICAL HEART VALVE

    INDICATION FOR USE

    The SJM Regent™ Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve. This device may also be used to replace a previously implanted aortic prosthetic valve.

    CONTRAINDICATIONS

    The SJM Regent™ Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.

    POTENTIAL ADVERSE EVENTS

    Complications are associated with replacement mechanical heart valves include, but are not limited to, hemolysis, infections, thrombus, or thromboembolism, valve dehiscence, unacceptable hemodynamic performance, hemorrhagic complications secondary to anticoagulation therapy, prosthetic failure, heart failure or death. Any of these complications may require reoperation or explantation of the device.

  • Rx Only

    AMPLATZER™ AMULET™ LEFT ATRIAL APPENDAGE OCCLUDER

    INDICATION FOR USE

    The Amplatzer™ Amulet™ Left Atrial Appendage Occluder is a percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.

    CONTRAINDICATIONS

    The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder is contraindicated for patients:

    • With the presence of intracardiac thrombus.
    • With active endocarditis or other infections producing bacteremia.
    • Where placement of the device would interfere with any intracardiac or intravascular structures.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events associated with the device or implant procedure include, but are not limited to, the following: Air embolism; Airway trauma; Allergic reaction; Anemia; Anesthesia reaction (nausea, vasovagal reaction, confusion/altered mental status or other); Arrhythmia; Atrial septal defect; Bleeding; Cardiac arrest; Cardiac tamponade; Chest pain/discomfort; Congestive heart failure; Death; Device embolization; Device erosion; Device malfunction; Device malposition; Device migration; Device-related thrombus; Fever; Hematuria; Hypertension/hypotension; Infection; Multi-organ failure; Myocardial infarction; Perforation; Pericardial effusion; Pleural effusion; Renal failure/dysfunction; Respiratory failure; Seizure; Significant residual flow; Stroke; Thrombocytopenia; Thromboembolism: peripheral and pulmonary; Thrombus formation; Transient ischemic attack; Valvular regurgitation/insufficiency; Vascular access site injury (hematoma, pseudoaneurysm, arteriovenous fistula, groin pain or other); Vessel trauma/injury.

  • Rx Only

    AMPLATZER™ TALISMAN™ PFO OCCLUDER

    INDICATION FOR USE


    The Amplatzer™ Talisman™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude other causes of ischemic stroke.

    CONTRAINDICATIONS

    Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained; Patients with intra-cardiac thrombus, mass, vegetation, or tumor; Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size; Patients with anatomy in which the required Amplatzer™ Talisman™ PFO device size would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins; Patients with another source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum; Patients with active endocarditis or other untreated infections; Patients who are unable to tolerate intra-procedural anticoagulation or post-procedural anti-platelet therapy.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus; Allergic reaction/toxic effect due to: anesthesia, contrast media, medication, or metal; Arrhythmia; Arteriovenous fistulae; Bleeding; Cardiac perforation; Cardiac tamponade; Chest pain; Death; Deep vein thrombosis; Device embolization; Device erosion; Endocarditis; Esophagus injury; Fever; Headache/migraine; Hematoma; Hypertension/hypotension; Infection; Myocardial infarction; Pacemaker placement secondary to PFO device closure; Pain; Pericardial effusion; Pericarditis; Peripheral embolism; Pseudoaneurysm; Pulmonary embolism; Reintervention for residual shunt/device removal; Stroke; Transient ischemic attack; Thrombus formation; Valvular regurgitation; Vascular access site injury; Vessel perforation.

  • Rx Only

    AMPLATZER™ SEPTAL OCCLUDER AND DELIVERY SYSTEM

    INDICATION FOR USE


    The Amplatzer™ Septal Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defects (ASD) in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration. Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement).

    CONTRAINDICATIONS

    The Amplatzer™ Septal Occluder is contraindicated for the following: Any patient known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery; Any patient known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement; Any patient known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy, unless another antiplatelet agent can be administered for 6 months; Any patient known to have a demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi); Any patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization; Any patient where the margins of the defect are less than 5 mm to the coronary sinus, inferior vena cava rim, AV valves, or right upper lobe pulmonary vein.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events may occur during or after a procedure placing this device may include, but are not limited to: Air embolus; Allergic dye reaction; Anesthesia reactions; Apnea; Arrhythmia; Cardiac tamponade; Death; Embolization; Fever Hypertension/hypotension; Infection including endocarditis; Need for surgery; Pericardial effusion; Perforation of vessel or myocardium; Pseudoaneurysm including blood loss requiring transfusion; Stroke; Tissue erosion; Thrombus formation on discs; Valvular regurgitation.

  • Rx Only

    AMPLATZER™ MUSCULAR VSD OCCLUDER

    INDICATION AND USAGE


    The Amplatzer™ Muscular VSD Occluder is indicated for use in patients with a complex ventricular septal defect (VSD) of significant size to warrant closure (large volume left-to-right shunt, pulmonary hypertension, and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.

    High-risk anatomical factors for transatrial or transarterial surgical closure include patients: Requiring left ventriculotomy or an extensive right ventriculotomy; With a failed previous VSD closure; With multiple apical and/or anterior muscular VSDs (“Swiss cheese septum”); With posterior apical VSDs covered by trabeculae.

    CONTRAINDICATIONS

    The Amplatzer™ Muscular VSD Occluder is contraindicated for the following: Patients with defects less than 4 mm distance from the semilunar (aortic and pulmonary) and atrioventricular valves (mitral and tricuspid); Patients with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease; Patients with perimembranous (close to the aortic valve) VSD; Patients with post-infarction VSD; Patients who weigh less than 5.2 kg. (Patients smaller than 5.2 kg were studied in the clinical trial, but due to poor outcome, these patients have been contraindicated for device placement. Data from these patients has not been included in the overall analysis); Patients with sepsis (local/generalized); Patients with active bacterial infections; Patients with contraindications to antiplatelet therapy or agents.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events that may occur during or after a procedure placing this device may include, but are not limited to: Air embolus; Allergic drug reaction; Allergic dye reaction; Anemia; Anesthesia reactions; Apnea; Arrhythmia; Arterial pulse loss; Atelectasis; Bacterial endocarditis; Blood loss requiring transfusion; Brachial plexus injury; Cardiac arrest; Cardiomyopathy; Chest pain; Cyanosis; Death; Device embolization; Device fracture; Fever; Headache/migraine; Heart block; Hypotension; Myocardial infarction; Perforation of the vessel or myocardium; Peripheral embolism; Stridor; Stroke; Subaortic stenosis; Thrombus formation on device; Vascular access site injury; Venous thrombosis; Vomiting.

  • Rx Only

    AMPLATZER PICCOLO™ OCCLUDER

    INDICATIONS AND USAGE

    The Amplatzer Piccolo™ Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).

    CONTRAINDICATIONS

    Weight < 700 grams at time of the procedure; Age < 3 days at time of procedure; Coarctation of the aorta; Left pulmonary artery stenosis; Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension; Intracardiac thrombus that may interfere with the implant procedure; Active infection requiring treatment at the time of implant; Patients with a PDA length smaller than 3 mm; Patients with a PDA diameter that is greater than 4 mm at the narrowest portion.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus, Allergic reaction, Anemia, Anesthesia reactions, Apnea, Arrhythmia, Bleeding, Cardiac perforation, Cardiac tamponade, Chest pain, Device embolization, Device erosion, Death, Endocarditis, Fever, Headache/migraine, Hemolysis, Hematoma, Hypertension, Hypotension, Infection, Myocardial infarction, Palpitations, Partial obstruction of aorta, Partial obstruction of pulmonary artery, Pericardial effusion, Pericarditis, Peripheral embolism, Pleural effusion, Pulmonary embolism, Re-intervention for device removal, Respiratory distress, Stroke, Thrombus, Transient ischemic attack, Valvular regurgitation, Vascular access site injury, Vascular occlusion, Vessel perforation.

  • Rx Only

    AMPLATZER™ DUCT OCCLUDER

    INDICATIONS AND USAGE

    The Amplatzer™ Duct Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).

    CONTRAINDICATIONS

    Patients weighing less than 6 kg; Patients less than 6 months of age; Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained; Active endocarditis or other infections producing bacteremia; Patients whose vasculature, through which access to the defect is gained, is inadequate to accommodate the appropriate sheath size; Patients with pulmonary hypertension with pulmonary vascular resistance of greater than 8 Wood units or Rp/Rs of greater than 0.4.

    POTENTIAL AND ADVERSE EVENTS

    Placement of the Amplatzer™ Duct Occluder involves using standard interventional cardiac catheterization techniques. The following events might occur from either the catheterization procedure or from the device: Air embolus; Allergic drug reaction; Allergic dye reaction; Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding; Brachial plexus injury; Chest pain; Death; Delivery system failure; Fever; Headache/migraine; Hypertension/hypotension; Myocardial infarction; Partial obstruction of aorta; Partial obstruction of pulmonary artery; Perforation of vessel or myocardium; Peripheral embolism; Stroke/transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site complications.

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