+
+
Stay Informed


BUILDING HEALTHIER
HEARTS

At Abbott we are committed to restoring health
and improving quality-of-life for people
living with structural heart disorders.

We are here to help you learn more about your heart, conditions that affect the heart, and how the treatment options available from Abbott can repair the damage caused by structural heart diseases and change peoples’ lives for the better. Our advanced solutions are designed to treat a wide range of conditions, including heart valve disease, congenital heart disease, and stroke risk.

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

HEART VALVE DISEASE

Mitral regurgitation and aortic stenosis are two of the most prevalent heart valve diseases, affecting millions of people worldwide.

Mitral Regurgitation

Mitral Regurgitation

Mitral regurgitation, or mitral valve regurgitation, is a type of heart valve disease in which the mitral valve does not close properly. 

LEARN MORE

Aortic Stenosis

Aortic Stenosis

Aortic stenosis is a serious and progressive heart valve disease. It is one of the most common heart valve diseases, affecting more than 20% of older people.1

LEARN MORE

DO YOU HAVE A HOLE IN YOUR HEART?

Learn about congenital heart defects and stroke risk associated with a PFO.

Atrial Septal Defect

Atrial
Septal Defect

LEARN ABOUT ASD

Ventricular Septal Defect

Ventricular
Septal Defect

LEARN ABOUT VSD

Patent Ductus Arteriosus

Patent
Ductus Arteriosus

LEARN ABOUT PDA

Patent Foramen Ovale

Patent
Foramen Ovale

LEARN ABOUT PFO

ARE YOU AT RISK OF STROKE?

AFib makes you 5 times more likely to have a stroke.1 Learn about stroke risk reduction.

LEARN MORE

GET BACK TO LIVING YOUR BEST LIFE

Learn about heart valve repair and replacement options to help restore a healthier heart.

EXPLORE TREATMENT OPTIONS

Find a doctor near me

Search for a doctor near you and book an appointment to answer any remaining questions you may have about different treatment options and therapies.

Show nearest:
Filter by:

MAT-2302757 v3.0 | Item approved for U.S. use only.

References
  1. Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 2014;6:213-220.
Important Safety Information
  • MitraClip
  • TriClip
  • Navitor
  • Epic Plus
  • Epic Max
  • Master Series
  • Amplatzer Amulet
  • Amplatzer Talisman PFO
  • Amplatzer Septal Occluder
  • Amplatzer Duct Occluder
  • Amplatzer Duct Occluder II
  • Amplatzer Piccolo Occluder
  • Amplatzer VSD Occluder
  • Amplatzer Muscular VSD Occluder

  • WHAT IS MITRACLIP™ THERAPY APPROVED FOR?
    Available by prescription only.

    MitraClip therapy is a minimally invasive procedure approved for treating patients with clinically significant mitral regurgitation due to either (a) a deteriorated mitral valve in patients who are deemed to be at prohibitive risk for surgery, or (b) mitral valve in patients who have heart failure and an enlarged heart who remain symptomatic on maximally tolerated medications to treat their heart failure.

    Patients should work with their doctor and a multidisciplinary heart team, which should include a heart surgeon and cardiologist with experience treating heart failure, to confirm their surgical risk or optimal medications. The heart team will determine if the patient meets the indications for the MitraClip procedure.

    WHO SHOULD NOT HAVE THE MITRACLIP PROCEDURE?

    Patients that have any of the following conditions should not have the MitraClip Procedure: inability to tolerate or are allergic or hypersensitive to anti coagulants, anti-platelet therapies, nickel, titanium, cobalt, chromium, polyester, or contrast dye; have inflammation or rheumatic disease of the valve; have blood clots inside the heart or blood vessels (inferior vena cava, femoral vein), or have mitral valve anatomy which is deemed not suitable for repair with Mitraclip.

    WHAT CAN HAPPEN TO ME DURING THE MITRACLIP PROCEDURE?

    As with most medical procedures, MitraClip Implant placement has risks, including inappropriate device placement, device movement from its implanted site, and failed or difficult delivery or retrieval of the device once implanted. Your physician will determine if you fall within the labeled indication for the MitraClip Procedure.

    WHO IS MORE AT RISK DURING THE MITRACLIP PROCEDURE?

    Even though MitraClip Therapy is a minimally invasive medical procedure, it carries risks, and some patients may be at a higher risk than others. If you have either a weak heart that may need support during the procedure or a rotated heart from prior heart surgery, talk to your doctor to weigh the additional risks to the benefits of the MitraClip Procedure as the safety and effectiveness has not been tested in these patients.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE MITRACLIP PROCEDURE?

    The MitraClip Procedure carries risks which include, but are not limited to: Allergic reactions to the implant materials or medications used during or after the procedure; Tissue damage at the puncture (entry site such as wound reopening, reaction to the catheter, bleeding, air bubbles, tissue or nerve injury; Inflammation, buildup of fluid or blood in the sac surrounding the heart, and complications that may require more interventions or heart surgery; Mitral valve complications including device dislodgement, entanglement with chords, narrowing of the mitral valve, continuing backflow of blood through the mitral valve during heart contraction, and inflammation; Abnormal heart rhythm, stroke (resulting from blood clot or burst vessel in the brain or transient stroke, high or low blood pressure; Multiple organ failure, death, pain; Complications related to the echocardiographic imaging such as irritation or perforation of the throat.

    Talk to your doctor to learn more about the risks associated with MitraClip Therapy, and ask for the detailed Important Safety Information if you'd like to review the full list of complications.

  • WHAT IS TRICLIP™ THERAPY APPROVED FOR?
    Available by prescription only.

    TriClip therapy is a minimally invasive procedure approved for treating patients with severe tricuspid valve regurgitation who continue to have symptoms despite being on heart failure medication, and who are at increased risk for surgery.

    Patients should work with their doctor and a multidisciplinary heart team with experience treating heart failure to confirm their surgical risk and to ensure that they are on the optimal medications. The heart team will determine if transcatheter edge-to-edge valve repair is clinically appropriate, is expected to reduce tricuspid valve regurgitation severity to moderate or less, and if the patient meets the indications for the TriClip procedure.

    WHO SHOULD NOT HAVE THE TRICLIP PROCEDURE?

    Patients that have any of the following conditions may not be good candidates for the TriClip Procedure: Patients with intolerance or allergy to procedural anticoagulation, untreatable hypersensitivity to implant components (nickel-titanium alloy, cobalt-chromium alloy), or active endocarditis or other active infection of the tricuspid valve.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE TRICLIP PROCEDURE?

    As with any medical procedure, there is a possibility of complications. The most serious complications of the TriClip™ Procedure include, but are not limited to: death, stroke, TIA (mini-stroke), major vascular complications which can include damage to a major blood vessel that may require surgery, and life-threatening bleeding events that require a blood transfusion. For additional potential risks and complications, please consult with your physician or heart team.

    Talk to your doctor to learn more about the risks associated with TriClip Therapy and ask for the detailed Important Safety Information if you'd like to review the full list of complications.

  • WHAT IS THE NAVITOR™ TAVI SYSTEM APPROVED FOR?
    Available by prescription only.

    Transcatheter Aortic Valve Implantation (TAVI) with the Navitor™ TAVI System provides an alternative, minimally invasive treatment option for people living with severe aortic stenosis, a condition where the aortic valve does not fully open or close, who are not candidates for open-heart surgery due to age, frailty, or other conditions that make surgery too risky.

    WHO SHOULD NOT RECEIVE TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE NAVITOR™ TAVI SYSTEM?

    You should not receive the Navitor valve if you have any of the following conditions: any kind of infection, including an active infection in the heart; cannot tolerate medication that thins the blood or prevents blood clots from forming; have a reaction or allergy to nitinol, an alloy of nickel and titanium.

    The Navitor™ TAVI System has not been studied in the following patient populations and therefore should not be used in patients who: have any evidence of a blood clot (thrombus), intracardiac mass or vegetation in, on or around the heart; have narrow veins or arteries with calcification that make insertion of the delivery sheath and access to the aortic valve impossible; have stenotic (narrowed) aortic valve without calcium deposits; have a heart valve defect from birth with either one or two leaflets vs. the normal three leaflets; are pregnant or breastfeeding; are age 21 or younger at the time of diagnosis or treatment; have an ejection fraction, or volume of blood fluid, less than 20%; have unstable heart function requiring mechanical assistance or drug therapy to support the normal function of the heart; are low or intermediate surgical risk; have had a previous heart valve or ring in any position in the heart; have mixed aortic valve disease (stenosis and regurgitation); have severe mitral valve disease (calcification, stenosis or inefficiency); have a medical condition that affects the cellular or plasma components of the blood; have significant coronary artery disease that requires treatment; have abnormally thick heart muscle (hypertrophic cardiomyopathy); are on dialysis, have kidney failure or inefficiency; have known allergy or sensitivity to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media/dye; have bulky calcium build up on the valve leaflets close to the coronary ostia which are the main arteries delivering blood from the heart to the rest of the body; have significant aortic disease, including abdominal aorta, thoracic aneurysm or any other folding, bending or narrowing which would make access to the aortic valve impossible.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE NAVITOR™ TAVI SYSTEM?

    There are risks with any heart valve implantation procedure. The most serious risks are: death, stroke, serious damage to the arteries and serious bleeding. Additional risks include, but are not limited to: access site complications (e.g., pain, bleeding, infection, blood vessel damage); buildup of deposits (plaque) in and on the walls of coronary arteries; heart attack - blockage of blood flow to the heart muscle; allergic reaction to medication or products/devices used during the procedure (medication to prevent blood clotting, x-ray die, components of the valve delivery process); tear or burst of the aorta; irregular heart rate; disruption or injury of electrical system in your heart leading to the need for a permenant pacemaker implant; tear or separation of the layers of the wall of an artery; obstruction of an artery, typically by a clot of blood or an air bubble; inflammation of the lining of your heart; failure of your heart to pump enough blood to the body’s organs; unstable blood flow; rupture or destruction of blood cells; blood cell damage; low red blood cell count; bleeding, infection, clotting in or on the valve or tissue of the valve; loose clots in the bloodstream that may block an artery in your arms, legs, or brain; escape of blood from a ruptured blood vessel; blood pressure changes above or below the normal levels; infection; reduced blood flow to your heart, preventing the heart muscle from receiving enough oxygen; changes to the Mitral valve where it doesn’t close tightly; multi-organ failure - inflammation from a severe infection or injury causes dysfunction in two or more organ systems; wrong sizing or positioning of the implanted valve; collection of fluid or blood around your heart; perforation or tear of the heart muscle, ventricle or blood vessel; formation of scar tissue that may cover or block the valve from functioning normally; leakage of blood around the edge of the valve; valves in your heart don’t close tightly, allowing blood to flow backward in your heart; kidneys lose the ability to remove waste and balance fluids; blood doesn’t have enough oxygen or has too much carbon dioxide; sepsis; structural deterioration of the implanted valve (i.e., calcification, leaflet tear); having an abnormal particle (air or blood clots) floating in the bloodstream or attached to an object, including the valve; when extra fluid builds up in the space around the heart; when the transcatheter valve moves or is dislodged from the deployment position/location; permanent disability; the need for additional medical procedures to include blood transfusions, operation to remove the valve, use of a balloon to adjust the valve (valvuloplasty), and catheter insertion into coronary arteries to treat blockages.

  • WHAT ARE THE EPIC™ PLUS VALVE AND EPIC™ PLUS SUPRA VALVE APPROVED FOR?
    Available by prescription only.

    The Epic™ Plus valve is for use in replacement of a native (natural) aortic and/or mitral heart valve that is diseased, damaged, or does not function properly. It may also be used to replace a previously implanted prosthetic aortic and/or mitral heart valve.

    The Epic™ Plus Supra valve is for use in replacement of a native (natural) aortic heart valve that is diseased, damaged, or does not function properly. It may also be used to replace a previously implanted prosthetic aortic heart valve.

    WHO SHOULD NOT RECEIVE THE EPIC™ PLUS VALVE OR EPIC™ PLUS SUPRA VALVE?

    There are no known contraindications with the use of the Epic™ Plus valve or Epic™ Plus Supra valve.

    WHAT ARE THE POSSIBLE COMPLICATION ASSOCIATED WITH THE EPIC™ PLUS VALVE OR EPIC™ PLUS SUPRA VALVE?

    Potential adverse events that may occur during or after implantation of the Epic™ Plus valve or Epic™ Plus Supra valve include, but are not limited to: chest pain; loss of regular heart rhythm; infection or inflammation in the heart; failure of the heart to pump enough blood for the body’s needs; destruction of red blood cells; anemia caused by excessive destruction of red blood cells; excessive bleeding related to use of blood thinners; leak near the valve; heart attack; nonstructural destruction of the valve; valve unable to close completely, thus allowing blood to flow backward through the valve; stroke; structural deterioration (calcification, leaflet tear, perforation, or other); blood clot that blocks a vessel; formation of a blood clot near or attached to the valve.

    It is possible that these complications could lead to reoperation, surgical removal of the valve, permanent disability, or death.

    WHAT ARE THE WARNINGS ASSOCIATED WITH THE EPIC™ PLUS VALVE OR EPIC™ PLUS SUPRA VALVE?

    Faster deterioration of the Epic™ Plus valve and Epic™ Plus Supra valve may occur in children, adolescents, or young adults; patients with a disease that results in more calcium in the blood, such as hyperparathyroidism or chronic renal failure; or individuals requiring hemodialysis.
    Talk to your doctor to learn more about the risks associated with use of the Epic™ Plus valve or Epic™ Plus Supra valve.

  • WHAT IS THE EPIC™ MAX VALVE APPROVED FOR?

    The Epic™ Max valve is for use in the replacement of a native (natural) aortic heart valve that is diseased, damaged, or does not function properly. It may also be used to replace a previously implanted aortic prosthetic heart valve. 

    WHO SHOULD NOT RECEIVE THE EPIC™ MAX VALVE?

    There are no known contraindications with the use of the Epic™ Max valve.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE EPIC™ MAX VALVE?

    Potential adverse events that may occur during or after implantation of the Epic™ Max valve (in alphabetical order) include, but are not limited to: chest pain; loss of regular heart rhythm; infection or inflammation in the heart; failure of the heart to pump enough blood for the body’s needs; destruction of red blood cells; anemia caused by excessive destruction of red blood cells; excessive bleeding related to use of blood thinners; leak near the valve; heart attack; nonstructural dysfunction of the valve; valve unable to close completely, thus allowing blood to flow backward through the valve; stroke; structural deterioration (calcification, leaflet tear, perforation, or other); blood clot that blocks a vessel; formation of a blood clot near or attached to the valve. 
    It is possible that these complications could lead to reoperation, surgical removal of the valve, permanent disability, or death.

    WHAT ARE THE WARNINGS ASSOCIATED WITH THE EPIC™ MAX VALVE?

    Faster deterioration of the Epic™ Max valve may occur in children, adolescents, or young adults; patients with a disease that results in more calcium in the blood, such as hyperparathyroidism or chronic renal failure; or individuals requiring hemodialysis.
    Talk to your doctor to learn more about the risks associated with use of the Epic™ Max valve.
     

  • WHAT IS THE SJM™ MASTERS SERIES MECHANICAL HEART VALVE APPROVED FOR?
    Available by prescription only.

    The SJM™ Masters Series Mechanical Heart Valve is for use in replacement of a native (natural) aortic or mitral heart valve that is diseased, damaged, or does not function properly. It may also be used to replace a previously implanted prosthetic aortic or mitral heart valve.

    WHO SHOULD NOT RECEIVE THE SJM™ MASTERS SERIES MECHANICAL HEART VALVE?

    Patients who are unable to tolerate blood-thinning medication should not receive the SJM™ Masters Series Mechanical Heart Valve.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE SJM™ MASTERS SERIES MECHANICAL HEART VALVE?

    Potential adverse events that may occur during or after implantation of the SJM™ Masters Series Mechanical Heart Valve include, but are not limited to: destruction of red blood cells; infections; blood clot that forms in a vein or blocks a vessel; breakdown of sutures that connect the valve to the heart; poor blood flow; excessive bleeding related to use of blood thinners; failure of the valve; heart failure; death.

    It is possible that these complications could lead to reoperation or surgical removal of the valve.

    Talk to your doctor to learn more about the risks associated with use of the SJM™ Masters Series Mechanical Heart Valve.

  • WHAT IS THE AMPLATZER™ AMULET™ LEFT ATRIAL
    APPENDAGE (LAA) OCCLUDER APPROVED FOR?
    Available by prescription only.

    The Amplatzer™ Amulet™ LAA Occluder is a device that is placed in the heart during a minimally invasive, catheter-based procedure to prevent blood clots from leaving the LAA in patients with atrial fibrillation who are at increased risk for stroke and are unable to take blood-thinning medication long-term.

    WHO SHOULD NOT RECEIVE THE AMPLATZER™ AMULET™ LAA OCCLUDER?

    Patients who have any of the following conditions should not receive the Amplatzer™ Amulet™ LAA Occluder: blood clots in the heart; active heart infection or other infections; anatomy in which the Amplatzer™ Amulet™ LAA Occluder would interfere with other heart structures, such as valves or veins.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE AMPLATZER™ AMULET™ LAA OCCLUDER?

    The Amulet LAAO procedure carries risks which include, but are not limited to: air bubble that blocks blood flow in a vessel; allergic reaction; anesthesia reactions; nausea; confusion; injury to the airway; difficulty breathing; fainting; loss of regular heart rhythm; a hole in the wall (septum) that separates the heart’s upper chambers; bleeding; low blood count; heart suddenly stops beating; blood or fluid buildup around the heart or lung; chest pain and/ or discomfort; death; obstruction of a blood vessel by all or part of an implanted device that entered the bloodstream; device erosion; device failure; device in wrong position; movement of the device to other parts of the body; blood clot on the device; fever; high or low blood pressure; infection; multiple organ failure; heart attack; perforation of the heart muscle or vessels; heart failure; kidney failure; seizure; continued blood flow into the LAA; temporary or permanent stroke; blood clot, including in the heart, leg, or lung; abnormal backward flow of blood through a valve; injury to the incision site; groin pain; blood clot under the skin in the groin; injury to a blood vessel.

    WHAT ARE THE WARNINGS ASSOCIATED WITH THE AMPLATZER™ AMULET™ LAA OCCLUDER?

    Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Patients may develop a build-up of fluid or blood around the heart and should contact their physician if they experience chest pain or difficulty breathing after implant.

    Talk to your doctor to learn more about the risks associated with the Amplatzer™ Amulet™ LAA Occluder.

  • WHAT IS THE AMPLATZER™ TALISMAN™ PFO
    OCCLUDER APPROVED FOR?
    Available by prescription only.

    The Amplatzer™ Talisman™ PFO Occluder is a device that is placed in the heart during a minimally invasive, catheter-based procedure to close a patent foramen ovale (PFO) to reduce the risk of another stroke in patients who have already had a stroke that was found to be related to the PFO.

    WHO SHOULD NOT RECEIVE THE AMPLATZER™ TALISMAN™ PFO OCCLUDER?

    Patients who have any of the following conditions should not receive the Amplatzer™ Talisman™ PFO Occluder: blood clots in the heart or blood vessels; mass, vegetation, or tumor inside the heart; heart or veins that are too small for the appropriate sheath size; anatomy in which the Amplatzer™ Talisman™ PFO Occluder would interfere with other heart structures, such as valves or veins; other sources of right to left shunts, including atrial septal defect; active heart infection or other untreated infections; or inability to take anticoagulant or antiplatelet therapy.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE AMPLATZER™ TALISMAN™ PFO OCCLUDER?

    Potential adverse events that may occur during or after a procedure using this device include, but are not limited to: air bubble that blocks blood flow in a vessel; allergic reaction to anesthesia, contrast dye, medication, or metal; loss of regular heart rhythm; abnormal connection between an artery and a vein; bleeding; perforation of the heart muscle or vessels; blood or fluid build-up around the heart; blood clot formation over the device or in the heart, leg, or lung; chest pain; death; obstruction of a blood vessel by all or part of an implanted device that entered the blood stream; device erosion; infection or inflammation in the heart; injury to the esophagus; fever; headache or migraine; high or low blood pressure; heart attack; pacemaker implant; pain; blood leakage outside a vessel; intervention to remove the device; stroke; temporary lack of oxygen to the brain; abnormal backward flow of blood through a valve; injury to the incision site.

    WHAT ARE THE WARNINGS ASSOCIATED WITH THE AMPLATZER™ TALISMAN™ PFO OCCLUDER?

    Patients at increased risk for blood clots may be prescribed a blood thinning medication following the procedure. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies.

    Talk to your doctor to learn more about the risks associated with the Amplatzer™ Talisman™ PFO Occluder.

  • WHAT IS THE AMPLATZER™ SEPTAL
    OCCLUDER APPROVED FOR?
    Available by prescription only.

    The Amplatzer™ Septal Occluder is a device that is placed in the heart during a minimally invasive, catheter-based procedure to close an atrial septal defect (ASD) in patients with an ostium secundum ASD.

    WHO SHOULD NOT RECEIVE THE AMPLATZER™ SEPTAL OCCLUDER?

    Patients who have any of the following conditions should not receive the Amplatzer™ Septal Occluder: other defects in the heart that require surgery to repair; infection anywhere in the body that cannot be successfully treated prior to receiving the device; bleeding disorder, untreated ulcer, or unable to take aspirin or other blood-thinning medication; blood clots in the heart; small size or any condition such as an active infection that makes the patient a poor candidate for the procedure; anatomy in which the device would interfere with or come in contact with other heart structures, such as valves or veins.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE AMPLATZER™ SEPTAL OCCLUDER?

    The Septal Occluder procedure carries risks which may include, but are not limited to: air bubble that blocks blood flow in a vessel; allergic reaction to contrast dye or anesthesia; temporary pause in breathing; loss of regular heart rhythm; blood or fluid buildup around the heart; death; obstruction of a blood vessel; fever; high or low blood pressure; infection, including infection or inflammation in the heart; need for surgery; fluid buildup around the heart; perforation of a vessel or the heart; blood leakage outside a vessel, including blood loss requiring a transfusion; erosion or abrasion of the tissue of the atrium; stroke; blood clot formation over the device; abnormal backward flow of blood through a valve.

    WHAT ARE THE PRECAUTIONS ASSOCIATED WITH THE AMPLATZER™ SEPTAL OCCLUDER?

    Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies.

    Talk to your doctor to learn more about the risks associated with the Amplatzer™ Septal Occluder.

  • WHAT IS THE AMPLATZER™ DUCT
    OCCLUDER APPROVED FOR?
    Available by prescription only.

    The Amplatzer™ Duct Occluder is a device that is placed in the heart during a minimally invasive, catheter-based procedure to close a patent ductus arteriosus (PDA).

    WHO SHOULD NOT RECEIVE THE AMPLATZER™ DUCT OCCLUDER?

    Patients who weigh less than 6 kg or are less than 6 months of age should not receive the Amplatzer™ Duct Occluder. Patients who have any of the following conditions should not receive the Amplatzer™ Duct Occluder: blood clot at the site of implant in the heart or in the blood vessels used to access the PDA; active heart infection or other infection; veins that are too small for the appropriate sheath size; high blood pressure in the pulmonary (lung) arteries.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE AMPLATZER™ DUCT OCCLUDER?

    The Duct Occluder procedure carries risks which may include, but are not limited to: air bubble that blocks blood flow in a vessel; allergic reaction to contrast dye, medication, or anesthesia; temporary pause in breathing; loss of regular heart rhythm; infection or inflammation in the heart; bleeding; weakness, loss of sensation, or loss of movement in the upper arm; chest pain; death; obstruction of a blood vessel by all or part of an implanted device that entered the bloodstream; fever; headache or migraine; high or low blood pressure; heart attack; partial obstruction of the aorta or pulmonary (lung) artery; perforation of a vessel or the heart; blood clot, including in the leg or lung; blood leakage outside a vessel; stroke or temporary lack of oxygen to the brain; abnormal backward flow of blood through a valve; injury to the incision site.

    WHAT ARE THE PRECAUTIONS ASSOCIATED WITH THE AMPLATZER™ DUCT OCCLUDER?

    Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies.

    Talk to your doctor to learn more about the risks associated with the Amplatzer™ Duct Occluder II.

  • WHAT IS THE AMPLATZER™ DUCT
    OCCLUDER II APPROVED FOR?
    Available by prescription only.

    The Amplatzer™ Duct Occluder II is a device that is placed in the heart during a minimally invasive, catheter-based procedure to close a patent ductus arteriosus (PDA).

    WHO SHOULD NOT RECEIVE THE AMPLATZER™ DUCT OCCLUDER II?

    Patients who weigh less than 6 kg or are less than 6 months of age should not receive the Amplatzer™ Duct Occluder II. Patients who have any of the following conditions should not receive the Amplatzer™ Duct Occluder II: PDA length less than 3 mm or greater than 12 mm; PDA diameter greater than 5.5 mm; active infection; blood clot at the site of implant in the heart; high blood pressure in the pulmonary (lung) arteries.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE AMPLATZER™ DUCT OCCLUDER II?

    The Duct Occluder II procedure carries risks which may include, but are not limited to: air bubble that blocks blood flow in a vessel; allergic reaction to contrast dye, medication, or anesthesia; temporary pause in breathing; loss of regular heart rhythm; infection or inflammation in the heart; bleeding; perforation of a vessel or the heart; blood or fluid buildup around the heart; chest pain; obstruction of a blood vessel by all or part of an implanted device that entered the bloodstream; device erosion; death; fever; headache or migraine; high or low blood pressure; heart attack; rapid or irregular beating of the heart; fluid buildup around the lung; blood clot, including in the leg or lung; intervention to remove the device; stroke; temporary lack of oxygen to the brain; abnormal backward flow of blood through a valve; injury to the incision site.

    WHAT ARE THE PRECAUTIONS ASSOCIATED WITH THE AMPLATZER™ DUCT OCCLUDER II?

    Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies.

    Talk to your doctor to learn more about the risks associated with the Amplatzer™ Duct Occluder II.

  • WHAT IS THE AMPLATZER PICCOLO™
    OCCLUDER APPROVED FOR?
    Available by prescription only.

    The Amplatzer Piccolo™ Occluder is a device that is placed in the heart during a minimally invasive, catheter-based procedure to close a patent ductus arteriosus (PDA).

    WHO SHOULD NOT RECEIVE THE AMPLATZER PICCOLO™ OCCLUDER?

    Patients who weigh less than 700 g or are less than 3 days of age should not receive the Amplatzer Piccolo™ Occluder. Patients who have any of the following conditions should not receive the Amplatzer Piccolo™ Occluder: narrowing of the aorta or of the left pulmonary (lung) artery; high blood pressure in the pulmonary arteries that requires blood flow to the rest of the body to go through the PDA; blood clot in the heart that may interfere with the implant procedure; active infection requiring treatment; PDA length less than 3 mm; PDA diameter at the narrowest portion greater than 4 mm.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE AMPLATZER PICCOLO™ OCCLUDER?

    The Piccolo Occluder procedure carries risks which may include, but are not limited to: air bubble that blocks blood flow in a vessel; allergic reaction; low number of red blood cells; anesthesia reaction; temporary pause in breathing; loss of regular heart rhythm; bleeding; perforation of a vessel or the heart; blood or fluid buildup around the heart; chest pain; obstruction of a blood vessel by all or part of an implanted device that entered the bloodstream; device erosion; death; infection or inflammation in the heart; fever; headache or migraine; destruction of red blood cells; collection of blood outside of a blood vessel; high or low blood pressure; infection; heart attack; rapid or irregular beating of the heart; partial obstruction of the aorta or pulmonary (lung) artery; blood clot, including in the leg or lung; fluid buildup around the lung; intervention to remove the device; difficulty breathing; stroke; temporary lack of oxygen to the brain; abnormal backward flow of blood through a valve; injury to the incision site; blockage of a blood vessel.

    WHAT ARE THE WARNINGS ASSOCIATED WITH THE AMPLATZER PICCOLO™ OCCLUDER?

    Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies.

    Talk to your doctor to learn more about the risks associated with the Amplatzer Piccolo™ Occluder.

  • WHAT IS THE AMPLATZER™ MUSCULAR VSD
    OCCLUDER APPROVED FOR?
    Available by prescription only.

    The Amplatzer™ Muscular VSD Occluder is a device that is placed in the heart during a minimally invasive, catheter-based procedure to close a muscular ventricular septal defect (VSD) in patients who are considered to be at high risk for traditional open-heart surgery.

    WHO SHOULD NOT RECEIVE THE AMPLATZER™ MUSCULAR VSD OCCLUDER?

    Patients who weigh less than 5.2 kg or who have any of the following conditions should not receive the Amplatzer™ Muscular VSD Occluder: VSD that is too close to any of the heart valves; disease affecting the blood vessels within the lungs; VSD that occurs after a heart attack; blood infection; active bacterial infection; unable to take blood-thinning medication.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE AMPLATZER™ MUSCULAR VSD OCCLUDER?

    The Muscular VSD Occluder procedure carries risks which include, but are not limited to: air bubble that blocks blood flow in a vessel; allergic reaction to contrast dye, medication, or anesthesia; low number of red blood cells; temporary pause in breathing; loss of regular heart rhythm; absence of a pulse; partial or complete collapse of the lung; infection or inflammation in the heart; blood loss requiring transfusion; weakness, loss of sensation, or loss of movement in the upper arm; heart suddenly stops beating; disease of the heart muscle; chest pain; bluish color to the skin due to a lack of oxygen in the blood; death; obstruction of a blood vessel by all or part of an implanted device that entered the bloodstream; fracture of the device; fever; headache or migraine; disruption of the electrical signal that controls the heartbeat; low blood pressure; heart attack; perforation of a vessel or the heart; blood clot formation over the device or in the heart, leg, or lung; noisy or high-pitched sound with breathing; stroke; narrowing of the area just below the aorta; injury to the incision site; vomiting.

    WHAT ARE THE PRECAUTIONS ASSOCIATED WITH THE AMPLATZER™ MUSCULAR VSD OCCLUDER?

    Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Aspirin or an alternative blood-thinning medication is recommended to be started at least 24 hours before the procedure and to continue for at least 6 months after the procedure.

    Talk to your doctor to learn more about the risks associated with the Amplatzer™ Muscular VSD Occluder.

  • WHAT IS THE AMPLATZER™ POST-INFARCT MUSCULAR
    VSD OCCLUDER APPROVED FOR?
    Available by prescription only.

    The Amplatzer™ Post-infarct Muscular VSD Occluder is a device that is placed in the heart during a minimally invasive, catheter-based procedure to close a muscular ventricular septal defect (VSD) that occurred after a heart attack in patients who are considered to be at high risk for traditional open-heart surgery.

    WHO SHOULD NOT RECEIVE THE AMPLATZER™ POST-INFARCT MUSCULAR VSD OCCLUDER?

    Patients who have any of the following conditions should not receive the Amplatzer™ Post-infarct Muscular VSD Occluder: VSD that is too close to the aortic or mitral valves; VSD that was present at birth; blood clot at the site of implant in the heart or in the blood vessels used to access the VSD; active heart infection, blood infection, or an infection anywhere in the body that cannot be successfully treated prior to receiving the device; veins that are too small for the appropriate sheath size; bleeding disorder, untreated ulcer, or unable to take aspirin or other blood-thinning medication.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE AMPLATZER™ POST-INFARCT MUSCULAR VSD OCCLUDER?

    The P.I. Muscular VSD Occluder procedure carries risks which may include, but are not limited to: air bubble that blocks blood flow in a vessel; allergic reaction; anesthesia reaction; low number of red blood cells; temporary pause in breathing; loss of regular heart rhythm; absence of a pulse; partial or complete collapse of the lung; infection or inflammation in the heart; bleeding; weakness, loss of sensation, or loss of movement in the upper arm; heart suddenly stops beating; disease of the heart muscle; bluish color to the skin due to a lack of oxygen in the blood; chest pain; death; obstruction of a blood vessel by all or part of an implanted device that entered the bloodstream; fracture of the device; fever; headache or migraine; disruption of the electrical signal that controls the heartbeat; heart is unable to pump enough blood to the body; destruction of red blood cells; high or low blood pressure; bulge in the wall of the left ventricle of the heart; heart attack; perforation of a vessel or the heart; blood clot in the heart, leg, or lung; loss of kidney function; difficulty breathing; blood infection; noisy or high-pitched sound with breathing; stroke; temporary lack of oxygen to the brain; narrowing of the area just below the aorta; low blood platelet count; abnormal backward flow of blood through a valve; injury to the incision site; vomiting.

    WHAT ARE THE PRECAUTIONS ASSOCIATED WITH THE AMPLATZER™ POST-INFARCT MUSCULAR VSD OCCLUDER?

    Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Aspirin is to be started at least 24 hours before the procedure.

    Talk to your doctor to learn more about the risks associated with the Amplatzer™ Post-infarct Muscular VSD Occluder.

Abbott Logo

Follow Abbott

Copyright © 2024 Abbott, 3200 Lakeside Dr, Santa Clara, 95054, U.S.A.
CAUTION: Product(s) intended for use by or under the direction of a physician. Prior to use, reference to the Instructions for Use, inside the product carton (when available) or at https://www.eifu.abbott/ for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
Illustrations are artist’s representations only and should not be considered as engineering drawings or photographs. Photos on file at Abbott.
Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates.
No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

MAT-2302755 v6.0  |   Item approved for U.S. use only.

Step 1

To implant the device, your doctor inserts a narrow tube into a vein in your upper leg.

+