+
+
Stay Informed
STRUCTURAL INTERVENTIONS

AMPLATZER™ VENTRICULAR SEPTAL DEFECT OCCLUDERS

Ventricular septal defects (VSDs) are the most commonly found congenital heart defect.2 Our Amplatzer™ VSD portfolio includes occluders specifically designed to close complex VSDs in patients considered to be too high risk for standard surgical repair.

THE PIONEER IN VENTRICULAR SEPTAL OCCLUDERS1

Abbott’s Amplatzer line not only pioneered structural heart defect occluders, it also retains a leadership position in structural heart innovation and treatment worldwide.1 Amplatzer™ VSD Occluders have a record of safety and effectiveness for more than 20 years.

A ventricular septal defect (VSD) is a hole in the septum between the ventricles and is the most common type of heart malformation.2 A VSD allows blood from the left ventricle to pass through into the right ventricle, creating extra stress to the right ventricle in order to keep up with the additional blood flow. Patients with a VSD carry an increased risk of infection to the heart walls and valves.
 

Types of VSD

There are 4 types of VSDs:

  • Perimembranous
  • Muscular
  • Conal, or subpulmonary
  • Inlet

Learn more about each type of VSD

Amplatzer options for Ventricular Septal Defect closure

Abbott offers two devices in the U.S. for transcatheter VSD closure, the Amplatzer Muscular VSD Occluder and the Amplatzer Post-MI Muscular VSD Occluder. Like many Amplatzer occluders, these devices:

  • Are self-expandable, double-disc devices
  • Are made of nitinol wire mesh with interwoven polyester substrate to promote occlusion and tissue in-growth
  • Can be recaptured and redeployed if necessary for precise placement
  • Are designed for complete closure
  • Have a symmetrical design that allows for a venous or arterial delivery approach
  • Have a connecting waist that corresponds to the size of the VSD*

*With the condition that the implanter chooses the appropriate device size.

The importance of treating patients with VSD

Josef - Amplatzer VSD

After receiving the Amplatzer™ VSD Occluder Jozef, amazed at his energy and ability to walk long distances again, said:

“I feel joy deep inside me—inside my heart.”

 

 

 

*This testimonial relates an account of an individual’s response to the treatment. This patient’s account is genuine, typical and documented. However, it does not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.

Amplatzer™ Muscular VSD Occluders

The Amplatzer™ Muscular VSD Occluder is indicated for use in patients with a complex VSD of significant size to warrant closure—large volume left-to-right shunt, pulmonary hypertension, and/or clinical symptoms of congestive heart failure—in patients 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.

Benefits, ease of transcatheter closure of VSDs

“The benefits of avoiding [cardiopulmonary] bypass are intuitive, and the relative ease of placement makes this procedure ultimately attractive.”3

  • When closure should be performed

    Both transcatheter and surgical closure are options for patients with moderate to large VSDs. In particular, physicians should perform VSD closure when the patient has2: 

    • Left ventricular (LV) volume overload and hemodynamically significant shunts, with pulmonary-to-systemic blood flow ratio (Qp/Qs) of 1.5 or higher*
    • Worsening aortic regurgitation (AR) caused by perimembranous VSD   

    In patients whose VSD is not repaired, there is an increased risk of infective endocarditis (IE), usually involving the tricuspid and pulmonary valves.

    *Assuming that pulmonary artery (PA) systolic pressure is less than 50% systemic and pulmonary vascular resistance is less than one-third systemic.

  • Treatment for Post-Mi Muscular VSD is critical

    A post-myocardial infarction muscular VSD is a life-threatening complication that often leads to cardiogenic shock.4 Notably, medical management alone is associated with a grim prognosis of a 94% mortality rate at 30 days.5

    The Amplatzer™ Post-infarct Muscular VSD Occluder is a percutaneous transcatheter occlusion device intended for closure of post-myocardial infarction muscular VSDs in patients who are not satisfactory surgical candidates.6

    Josef - Amplatzer VSD

    Amplatzer was “Just the right device” for VSD

    Cardiologist

    Due to his VSD, Jozef developed endocarditis, which in turn led to heart failure and kidney failure. After receiving an Amplatzer VSD Occluder, Jozef, astonished at his symptom improvement, noted “I feel joy deep inside me—inside my heart.”

Choose between two Amplatzer™ devices for
Muscular VSD Closure

Abbott’s 2 muscular VSD occluders allow for either a femoral or an arterial delivery.


Amplatzer™ Muscular VSD Occluder

  • Is designed for muscular VSD closure in patients considered to be high risk for standard surgical repair
  • Has a 7 mm waist length to accommodate the thickness of the muscular septal wall


Amplatzer™ P.I. Muscular VSD Occluder

  • Is designed for the damaged muscular tissue in the septal wall of patients who have had a myocardial infarction
  • Has a 10 mm waist length to accommodate the damaged tissue that can occur with septal wall rupture
Abbott Amplatzer Portfolio App helps physicians determine which structural intervention device to use

NEW VERSION AVAILABLE
GET THE AMPLATZER PORTFOLIO APP

The Amplatzer Portfolio App helps physicians determine which Amplatzer Structural Interventions device to use by suggesting applicable devices based on respective Instructions for Use.
 

App Store
Google Play

MAT-2008371 v4.0 | Item approved for U.S. use only.

References
  1. Data on file at Abbott.
  2. Stout KK, Daniels CJ, Aboulhosn JA, et al. 2018 AHA/ACC Guideline for the Management of Adults with Congenital Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;73(12):e81-e192. doi: 10.1161/CIR.0000000000000603.
  3. Minette MS, Sahn DJ. Ventricular septal defects. Circulation. 2006;114:2190-2197.
  4. Schlotter F, de Waha S, Eitel I, et al. Interventional post-myocardial infarction ventricular septal defect closure: a systematic review of current evidence. EuroIntervention. 2016;12:94-102.
  5. Crenshaw BS, Granger CB , Birnbaum Y, et al. Risk factors, angiographic patterns, and outcomes in patients with ventricular septal defect complicating acute myocardial infarction. Circulation. 2000;101(1):27-32.
  6. Amplatzer Post-infarct Muscular VSD Occluder Instructions for Use.
Important Safety Information
  • AMPLATZER™ Muscular VSD Occluder
  • AMPLATZER™ Post-infarct Muscular VSD Occluder

  • Rx Only

    AMPLATZER™ MUSCULAR VSD OCCLUDER

    INDICATION AND USAGE


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

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

    CONTRAINDICATIONS

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

    POTENTIAL ADVERSE EVENTS

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

  • Rx Only

    AMPLATZER™ P.I. MUSCULAR VSD OCCLUDER
    INDICATIONS AND USAGE


    The Amplatzer™ Post-infarct Muscular VSD Occluder is a percutaneous transcatheter occlusion device intended for closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates.

    CONTRAINDICATIONS

    The Amplatzer™ Post-infarct Muscular VSD Occluder is contraindicated for the following: Patients with perimembranous VSDs or a VSDs close to the aortic or mitral valve; Patients with congenital muscular VSDs; Patients with the 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 active endocarditis or other infections producing bacteremia; Patients whose vasculature, through which access to the defect is gained, is inadequate to accommodate the appropriate sheath size; Patients known to have active sepsis 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.

    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 reaction; Anemia; Anesthesia reaction; Apnea; Arrhythmia; Arterial pulse loss; Atelectasis; Bacterial endocarditis; Bleeding; Brachial plexus injury; Cardiac arrest; Cardiomyopathy; Cyanosis; Chest pain; Death; Device embolization; Device fracture; Fever; Headache/migraine; Heart block; Heart failure; Hemolysis; Hypertension; Hypotension; Left ventricular aneurysm; Myocardial infarction; Perforation of vessel or myocardium; Peripheral embolism; Renal insufficiency; Respiratory arrest; Sepsis; Stridor; Stroke/TIA; Sub-aortic stenosis; Thrombocytopenia; Thrombus; Valvular regurgitation/insufficiency; Vascular access site complications; Venous thrombosis; Vomiting.

YOU ARE ABOUT TO ENTER AN ABBOTT COUNTRY OR REGION SPECIFIC WEBSITE.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of the product that are not approved in other countries or regions.

U.S. VISITOR INTERNATIONAL VISITOR

YOU ARE ABOUT TO LEAVE
www.structural­heart.abbott

You are now leaving www.structuralheart.abbott. Abbott is not responsible for any content published on the third-party website you are about to enter. Abbott has not reviewed and does not endorse any information presented on third-party websites.

OkCancel
+