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Heart Solutions
Built For
Better LIFE

At Abbott, we’re helping rebuild better hearts and improve patients’ quality of life with an improved benefit-to-risk profile by delivering better therapies, better evidence, and better experiences.1

Our Solutions         ABOUT US

From their first moments through their later years, we exist for one purpose—to help our patients live better, fuller lives.

These testimonials relate to accounts of individuals’ responses to treatments. The patients’ accounts are genuine, typical, and documented. However, it does 
not provide any indication, guide, warranty, or guarantee as to the response other persons may have to a treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.

Navitor™ TAVI System is now available for patients with severe aortic stenosis who are at high or greater risk for surgery

Navitor is designed with patient lifetime management in mind and offers patient and physician benefits:

  • TODAY |  Easy, calm, and stable deployment.
    Deliverability
    Ease of Use

  • TOMORROW |  Excellent hemodynamics.
    Single Digit Gradients2
    Minimal Prosthesis-Patient Mismatch3
    Excellent PVL Mitigation2

  • THE ROAD AHEAD |  Uncompromised coronary access for future procedures.
    Coronary Access
    Lowest Neoskirt Height4​​​​​​​*

Learn more

*Among commercially available self-expanding TAVI valves.

MAT-2008871 v7.0 | Item approved for U.S. use only.

References
  1. Data on file at Abbott.
  2. Navitor™ TAVI System IFU.
  3. Abbott data on file CL1020663.
  4. Akodad M, Sellers S, Gulsin GS, et al. Leaflet and neoskirt height intranscatheter heart valves: implications for repeat procedures and coronary access. JACC Cardiovasc Interv. 2021;14(20):2298-2300. doi:10.1016/j.jcin.2021.07.034
Important Safety Information
  • MitraClip
  • Navitor
  • Amplatzer PFO
  • Amplatzer Amulet
  • MASTERS SERIES
  • Amplatzer Piccolo Occluders
  • Amplatzer VSD Occluders

  • MITRACLIP DELIVERY SYSTEMS
    INDICATION FOR USE
     

    • The MitraClip™ 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 MitraClip™ 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

  • 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.

  • 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-lehunts, 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.

    WARNINGS

    • Do not use an open or damaged pouch; do not use a damaged device.
    • Patients who are at increased risk for venous thromboembolic events should be managed with thromboembolic risk reduction regimen after the PFO closure following standard of care.
    • The safety and effectiveness of the Amplatzer™ Talisman™ PFO Occluder has not been established in patients with a hypercoagulable state.
    • Prepare for situations that require percutaneous or surgical removal of this device. This includes availability of a surgeon and access to operating room.
    • Embolized devices must be removed as they may disrupt critical cardiac functions. Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter or sheath.
    • The Amplatzer™ Talisman™ PFO Occluder device consists of a nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty breathing or inflammation of the face or throat. Some patients may also develop an allergy to nickel if this device is implanted.
    • Transient hemodynamic compromise may be encountered during device placement, which may require fluid replacement or other medications as determined by the physician.
    • Prior to device detachment, evaluate the position of the device relative to the free atrial wall and the aortic root using echocardiography.
    • Use echocardiography to ensure that the device does not impinge on the free atrial wall or aortic root.
    • Do not release the device from the delivery cable if the device does not conform to its original configuration, or if the device position is unstable or if the device interferes with any adjacent cardiac structure (such as Superior Vena Cava (SVC), Pulmonary Vein (PV), Mitral Valve (MV), Coronary Sinus (CS), aorta (AO)). If the device interferes with an adjacent cardiac structure, recapture the device and redeploy. If still unsatisfactory, recapture the device and either replace with a new device or consider alternative treatments.
    • DO NOT use the Amplatzer™ Talisman™ PFO Occluder after the Use-by date stated on the package label.
    • This device was sterilized with ethylene oxide and is for single use only. Never reuse or re-sterilize the system. Use of expired, reused, or re-sterilized devices may result in infection.
    • This device should be used only by physicians who are trained in standard transcatheter techniques.

    PRECAUTIONS FOR SPECIAL POPULATIONS

    • Pregnancy: The safety and effectiveness of this occluder has not been established during pregnancy. Fluoroscopic x-ray guidance is used during placement of the device. The risk of increased X-ray exposure for patients who are pregnant must be weighed against the potential benefits of this technique.
    • Nursing mother: The safety and effectiveness of this occluder has not been established in lactating mothers. There has been no quantitative assessment for the presence of leachables in breast milk.
    • Pediatric Population: The safety and effectiveness of this occluder has not been established in a pediatric population.

    PRECAUTIONS

    • Aspirin(325mg/day)(oralternativeantiplatelet/anticoagulant,if patient has aspirin intolerance) is recommended to be started at least 24 hours prior to the procedure.
    • Antibiotics should be administered peri-procedurally.
    • Patients should be fully heparinized throughout the procedure using adequate dosing so as to keep the activated clotting time (ACT) greater than 200 seconds.

    CAUTION: Intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) is recommended as an aid in evaluating the PFO and placing the AmplatzerTM TalismanTM PFO Occluder. If TEE is used, the patient’s esophageal anatomy must be adequate for placement.

    CAUTION: Be cautious when using fluoroscopic X-ray guidance, which may be used during placement of the device.

    CAUTION: Do not use a power injection system to put contrast solution through the sheath.

    • The safety and effectiveness of the AmplatzerTM TalismanTM PFO Occluder has not been established in patients (with):
      • Age less than 18 years or greater than 60 years because enrollment in the pivotal study (the RESPECT trial) was limited to patients 18 to 60 years old
      • A hypercoagulable state including those with a positive test for a anticardiolipin antibody (IgG or IgM), Lupus anticoagulant, beta-2 glycoprotein-1 antibodies, or persistently elevated fasting plasma homocysteine despite medical therapy
      • Unable to take antiplatelet therapy
      • Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a ≥50% luminal stenosis
      • Acute or recent (within 6 months) myocardial infarction or unstable angina
      • Left ventricular aneurysm or akinesis
      • Mitral valve stenosis or severe mitral regurgitation, irrespective of etiology
      • Aortic valve stenosis (mean gradient greater than 40 mmHg) or severe aortic valve regurgitation
      • Mitral or aortic valve vegetation or prosthesis
      • Aortic arch plaques protruding greater than 4 mm into the aortic lumen
      • Left ventricular dilated cardiomyopathy with left ventricular ejection fraction (LVEF) less than 35%
      • Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
      • Uncontrolled hypertension or uncontrolled diabetes mellitus
      • Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying stroke event
      • Arterial dissection as cause of stroke
      • Index stroke of poor outcome (modified Rankin score greater than 3)
      • Pregnancy at the time of implant
      • Multi-organ failure

    PATIENT COUNSELING INFORMATION

    Physicians should review the following information when counseling patients about the AmplatzerTM TalismanTM PFO Occluder and the implant procedure:

    • The safety and effectiveness of PFO closure withthe AmplatzerTM TalismanTM PFO Occluder in combination with the required post- implant antiplatelet therapy.
    • PFO closure with the AmplatzerTM TalismanTM PFO Occluder can only reduce the risk for a recurrent stroke due to a paradoxical embolism through a PFO.
      • With aging, there is an increased likelihood that non-PFO related risks for stroke may develop and cause a recurrent ischemic stroke independent of PFO closure.
    • The procedural risks associated with AmplatzerTM TalismanTM PFO Occluder.
    • The need for adherence to a defined adjunctive antithrombotic therapy following implantation of the AmplatzerTM TalismanTM PFO Occluder.
    • Patients with a history of DVT or PE may benefit from continuation or resumption of anticoagulation therapy following implantation of the AmplatzerTM TalismanTM PFO Occluder to reduce the risk of recurrent DVT or PE.

    It is recommended that the medical team (neurologist and cardiologist) and the patient engage in a shared decision-making process and discuss the risks and benefits of PFO closure in comparison to using antithrombotic therapy alone, while taking into account the patient’s values and preferences.

    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

  • 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

  • SJM™ MASTERS SERIES
    MECHANICAL HEART VALVE


    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 prosthetic heart valve.

    CONTRAINDICATIONS

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

    WARNINGS

    • For single use only. Attempts to reuse the valve may result in valve malfunction, inadequate sterilization, or patient harm.
    • Do not use if:
      • The valve has been dropped, damaged, or mishandled in any way.
      • The expiration date has elapsed.
      • The tamper-evident container seal or inner/outer tray seals are damaged, broken or missing.
    • Remove any residual tissue that may impair valve size selection, correct seating of the valve, rotation of the valve, or leaflet motion.
    • Proper valve size selection is crucial. Do not oversize the valve. If the native annulus measurement falls between two SJM™ Masters Series Mechanical Heart Valve sizes, use the smaller size SJM™ Masters Series Mechanical Heart Valve.
    • Use only St. Jude Medical™ mechanical heart valve sizers.
    • The outer tray is not sterile, and should not be placed in the sterile field.
    • To minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.
    • Do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications. Use a St. Jude Medical™ leaflet tester to gently test valve leaflet mobility.
    • Place sutures in the outer half of the valve sewing cuff.
    • Never apply force to the valve leaflets. Force may cause structural damage to the valve.
    • Use only SJM™ Valve Holder/Rotators to perform valve rotation. Use of other instruments could result in structural damage. The valve holder/ rotator is intended for single use only and should be discarded after surgery.
    • The two retention sutures on the valve holder/ rotator must be cut and removed before the SJM™ Masters Series Mechanical Heart Valve can be rotated.
    • Do not pass catheters or other instruments through St. Jude Medical™ mechanical heart valves. This could result in scratched or damaged valve components, or leaflet fracture or dislodgment.
    • Cut suture ends short, especially in the vicinity of the pivot guards, to prevent leaflet impingement.
    • Three cases of impeded leaflet motion not satisfactorily explained were reported in a survey of 149 centers reporting on 4,934 patients implanted over a period of three (3) years. A number of other cases occurred early in the investigation of this prosthesis; however, the rates of occurrence are not statistically determinable.

    PRECAUTIONS

    • Do not touch the prosthetic valve unnecessarily, even with gloved hands. This may cause scratches or surface imperfections that may lead to thrombus formation.
    • Be careful not to cut or tear the valve sewing cuff when removing the identification tag and the holder/rotator from the SJM™ Masters Series Mechanical Heart Valve.
    • Before placing sutures in the valve sewing cuff, verify that the valve is mounted correctly on the valve holder/rotator.
    • To avoid structural damage, the valve must be rotated in the fully closed position.
    • To minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve (Figures 15a and 15b).
    • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.

    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; and heart failure or death.

    Any of these complications may require reoperation or explantation of the device.

  • AMPLATZER PICCOLOTM OCCLUDER
    INDICATIONS AND USAGE

    The AMPLATZER PiccoloTM 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

  • 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 COMPLICATIONS AND ADVERSE EVENTS

    Potential adverse events may occur during or after a procedure using this device may include, but are not limited to:

    Potential adverse events may occur during or after a procedure using 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

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