The Amplatzer portfolio of structural intervention occluders provides minimally invasive treatment options for the closure of congenital heart defects and for stroke risk reduction. The closure procedures are performed through a transcatheter approach, which prevents the need for open heart surgery and enables faster recovery times.
The Amplatzer Family of Duct Occluders offers an extensive line of devices and a simple treatment option for the closure of patent ductus arteriosus (PDA). Amplatzer™ Duct Occluders are designed to occlude PDAs of various shapes and sizes. With an easy-to-perform deployment procedure, the implanting physician can be confident in placing the device with precision.
Ventricular septal defects (VSD) are the most commonly found congenital heart defect.3 One subtype of these defects is muscular VSD. If left untreated it can lead to pulmonary hypertension and/or congestive heart failure.4 The Amplatzer™ Muscular VSD Occluders are designed for complete closure of these type of defects.
Amplatzer™ Septal Occluders are the standard of care for minimally invasive atrial septal defect (ASD) closure.1,2 These double-disc occluders are comprised of nitinol mesh and polyester material. They are designed to securely appose the septal wall on each side of the defect and create a platform for tissue in-growth after implantation.
The Amplatzer™ Talisman™ PFO Occluder set the standard, pioneering treatment with a device developed specifically for patent foramen ovale (PFO) closure to reduce the risk of recurrent ischemic stroke. It’s the leading PFO closure device to date, with over 180,000 devices implanted worldwide.5
The Amplatzer™ Amulet™ Left Atrial Appendage Occluder is the only FDA-approved LAA occluder that offers immediate freedom from OACs. With unique dual seal technology to ensure immediate and complete closure and the widest range of sizes of any LAA occluder, Amulet™ makes closure an option for more AFib patients.6
Indications and Usage
The AMPLATZER™ Duct Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).
Contraindications
Warnings
Precautions
Handling
The AMPLATZER™ Duct Occluder and 180° Delivery System were sterilized with ethylene oxide and are for single use only. Do not reuse or resterilize. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
Sizing
Accurate defect sizing is crucial and mandatory for AMPLATZER™ Duct Occluder device selection. Refer to Table 4 for sizing instructions.
Procedural
Post-implant
MR Conditional to 3.0 Tesla
Use in Specific Populations
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 dye reaction; Allergic drug reaction; Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding; Cardiac perforation; Cardiac tamponade; Chest pain; Device embolization; Device erosion; Death; Fever; Headache/migraine; Hypertension; Hypotension; Myocardial infarction; Palpitations; Pericardial effusion; Pericarditis; Peripheral embolism; Pleural effusion; Pulmonary embolism; Reintervention for device removal; Stroke; Transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site injury; and Vessel perforation.
Indications 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:
Contraindications
The AMPLATZER™ Muscular VSD Occluder is contraindicated for the following:
Warnings
Precautions
Handling
Store in a dry place.
Sizing
Accurate defect sizing is crucial and mandatory for AMPLATZER™ Muscular VSD Occluder device selection. The VSD should be assessed and sized at end diastole by transesophogeal echocardiography (TEE) or angiography to determine the appropriate device size. Device selection should be 2 mm larger than the defect size.
Procedural
Post-implant
Use in Specific Populations
MR Conditional1
Through non-clinical testing, AMPLATZER™ devices have been shown to be MR Conditional. A patient with an implanted AMPLATZER™ device can be scanned safely immediately after placement of the device under the following conditions:
During testing, the device produced a clinically non-significant temperature rise at a maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning in a 3-tesla MR system using a transmit/receive body coil.
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
1. MR Conditional as defined in ASTM F 2503-05.
Potential Adverse Events
Potential adverse events may occur during or after a procedure using this device may include, but are not limited to:
Indications 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:
Warnings
Precautions
Handling
Store in a dry place.
Procedural
Post-implant
Use in Specific Populations
MR Conditional to 3.0 Tesla
Caution should be used if an MRI is performed with a magnetic field of >3.0 tesla. Through non-clinical testing, the AMPLATZER™ device has been known to be MR Conditional at field strengths of 3.0 tesla or less with a maximum whole-body-averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 tesla and 5.57 W/kg at 5.0 tesla for a 20-minute exposure to a B1 of 118 μT. The AMPLATZER™ device should not migrate in this MR environment. Non-clinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla.
In this testing, the device produced a temperature rise of 1.1°C at 1.5 tesla and 1.6°C at 5.0 tesla.
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.
Potential Adverse Events
Potential adverse events may occur during or after a procedure placing this device may include, but are not limited to:
Indications 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
Warnings
Precautions for Special Populations
Precuations
CAUTION: Intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) is recommended as an aid in evaluating the PFO and placing the Amplatzer™ Talisman™ 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.
Patient Counseling Information
Physicians should review the following information when counseling patients about the Amplatzer™ Talisman™ PFO Occluder and the implant procedure:
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:
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:
Warnings:
Precautions:
MRI Safety Information: Non-clinical testing has demonstrated that the Amplatzer™ Amulet™ Left Atrial Appendage Occluder device is MR Conditional. A patient with the Amplatzer™Amulet™ device can be safely scanned in an MR system under the following conditions:
Under the scan conditions defined above, the device is expected to produce a maximum temperature rise of less than or equal to 4°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends radially up to 20 mm from the device when imaged with a gradient echo pulse sequence in a 3.0T MR system.
Potential Adverse Events: Potential adverse events associated with the device or implant procedure include, but are not limited to, the following:
MAT-2008014 v3.0 | Item approved for U.S. use only.