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SOLUTIONS & PRODUCTS

From transcatheter and surgical valve therapies to structural interventions,

we’ve built a broad structural heart portfolio across the spectrum to restore health and improve quality of life for patients with structural heart disease.

YOUR PARTNER OF CHOICE
FOR STRUCTURAL HEART SOLUTIONS

Abbott offers a broad portfolio of structural heart solutions for an array of conditions. We invest in creating innovative technologies and advancing science, with the ultimate goal of helping patients achieve better health and improved quality of life. With our legacy of innovation, product diversity, safety, and performance, Abbott is your partner for structural heart therapies.

Some of the ways Abbott demonstrates its leadership in the industry include:

  • Established leader in transcatheter edge-to-edge repair (TEER)* with MitraClipTM1
  • Offering among the broadest occluder portfolios, with 20+ years of leadership1
  • Demonstrating exceptional hemodynamics with tissue valves, and an impressive 40-year legacy with mechanical valves
  • Providing outstanding & competitive clinical outcomes physicians expect from the latest generation TAVI system


*TEER is also referred to as TMVr (transcatheter mitral valve repair)

150K+

patients treated
 

Established leader in
transcatheter mitral valve repair
with MitraClipTM 1

20+

years of leadership
in occluders

We offer a broad portfolio
with PFO, LAA, PDA, septal,
and muscular VSD occluders

40

year legacy
 

We have an impressive 40-year legacy with mechanical valves and have demonstrated exceptional hemodynamics with tissue valves

Transcatheter mitral valve repair therapy

TRANSCATHETER VALVE SOLUTIONS

BUILT TO HELP
PATIENTS RECLAIM
THEIR LIVES

Our minimally invasive transcatheter mitral valve repair therapy delivers excellent outcomes, and are particularly valuable for select patients who are not eligible for surgical valve repair.

EXPLORE TRANSCATHETER VALVE SOLUTIONS

SURGICAL VALVE SOLUTIONS

DESIGNED TO REBUILD HEALTHIER HEARTS

Our comprehensive surgical valve portfolio delivers long-term durability and performance, exceptional hemodynamics, and streamlined implantability.

Explore SURGICAL VALVE SOLUTIONS

Surgical valve solutions
Surgical valve solutions

SURGICAL VALVE SOLUTIONS

DESIGNED TO REBUILD HEALTHIER HEARTS

Our comprehensive surgical valve portfolio delivers long-term durability and performance, exceptional hemodynamics, and streamlined implantability.

Explore SURGICAL VALVE SOLUTIONS

Structural intervention, occluder for stroke risk reduction

STRUCTURAL INTERVENTIONS

BUILT FOR THE AGES.
DESIGNED FOR
COMPLETE CLOSURE.

Our occluders are built to close an opening in patients’ hearts—saving and restoring lives by providing closure with confidence.

Explore structural interventionS

Explore the interactive heart model below to learn more about our products and solutions across the structural heart spectrum.

Mitral Regurgitation

A condition in which the mitral valve does not close completely during the contraction of the left ventricle, causing blood to leak backward into the left atrium.
Click on a product name to learn more about our therapy solutions

  • MitraClipTM Therapy

    MitraClipTM Therapy is a minimally invasive TMVr therapy that delivers a treatment option for select patients with mitral regurgitation who would otherwise go untreated.*
    *TMVr is also referred to as TEER (Transcatheter edge-to-edge repair)
    MitraClip Therapy for mitral regurgitation
    Learn More

  • EpicTM Plus Mitral Stented Tissue Valve

    The EpicTM Plus Mitral stented tissue valve is intended for patients requiring replacement of a diseased, damaged, or malfunctioning native or prosthetic mitral heart valve.
    Epic Plus Supra stented tissue valve
    Learn More
EpicTM Plus MitralMitraClipTM
×

Aortic Stenosis

A narrowing of the aortic valve, which reduces or blocks blood flow from the left ventricle to the aorta.
Click on a product name to learn more about our therapy solutions

  • PorticoTM Valve

    The PorticoTM with FlexNavTM TAVI system is a minimally invasive treatment for patients with aortic valve stenosis.
    Abbott Portico with FlexNav TAVI system
    Learn More

  • EpicTM Plus Supra Stented Tissue Valve

    The EpicTM Plus Supra stented tissue valve is intended for patients requiring replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.
    Epic Plus Supra stented tissue valve
    Learn More

  • RegentTM MHV

    The RegentTM mechanical heart valve is intended for patients requiring replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic valve.
    Regent MHV
    Learn More
PorticoTMEpicTM Plus SupraRegentTM
×

Stroke Risk Reduction

Left atrial appendage (LAA) closure reduces the risk of stroke in non-valvular AF patient. Percutaneous closure of the patent foramen ovale (PFO) to prevent thrombus formation.
Click on a product name to learn more about our therapy solutions

  • AmplatzerTM AmuletTM LAA Occluder

    A percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in suitable patients with nonvalvular atrial fibrillation.
    Amplatzer Amulet occluder for atrial fibrillation
    Learn More

  • AmplatzerTM TalismanTM PFO Occluder

    Designed for patent foramen ovale (PFO) closure, the AmplatzerTM TalismanTM PFO occluder reduces the risk of recurrent ischemic stroke.
    Amplatzer Talisman PFO occluder
    Learn More
AmplatzerTM AmuletTM LAA OccluderAmplatzerTM TalismanTM PFO Occluder
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Congenital defects

Congenital heart defects can involve the walls of the heart, the heart valves, and arteries and veins near the heart, disrupting normal blood flow.
Click on a product name to learn more about our therapy solutions

  • AmplatzerTM Septal Occluder

    A percutaneous transcatheter device for patients requiring atrial septal defect (ASD) closure.
    Amplatzer Septal occluder
    Learn More

  • AmplatzerTM VSD Occluder

    Ventricular septal defects (VSDs) are the most common congenital heart defect, and AmplatzerTM Muscular VSD Occluders provide minimally invasive treatment options.
    Amplatzer VSD occluder
    Learn More
AmplatzerTM Septal OccluderAmplatzerTM VSD Occluder
×
© 2023 Abbott. All rights reserved. MAT-2115844 v3.0 | Item approved for U.S. use only.

MAT-2004253 v8.0 | Item approved for U.S. use only.

References
  1. Data on file at Abbott.
Important Safety Information
  • MitraClip
  • EPIC PLUS
  • Portico
  • Amplatzer Talisman PFO
  • Regent
  • AMPLATZER ASD
  • Amplatzer VSD

  • Rx Only

    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.

  • 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

    PORTICO™ TRANSCATHETER AORTIC VALVE IMPLANTATION SYSTEM

    INDICATIONS

    The Portico™ 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

    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.

  • SJM REGENTTM MECHANICAL HEART VALVE
    INDICATION FOR USE


    The SJM RegentTM 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 heart valve.

    CONTRAINDICATIONS

    The SJM RegentTM 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; and heart failure or death. Any of these complications may require reoperation or explantation of the device.

  • 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.

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