What is an Amplatzer duct occluder II?
The AMPLATZER™ Duct Occluder II is a percutaneous transcatheter occlusion device intended for the non-surgical closure of patent ductus arteriosus.
What is a AMPLATZER Duct Occluder?
The Amplatzer Duct Occluder (AGA Medical Corporation, Golden Valley, MN) is a self-expanding and self-centering device, made from 0.0004 to 0.0005 inch Nitinol wire mesh. It is mushroom-shaped with a low profile and consists of a flat retention disk and a cylindrical main body, into which polyester fibers are sewn.
What is ADO 2?
Sponsor: Abbott Medical Devices. Abbott Medical Devices. Brief Summary: The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA).
What is PDA in heart disease?
Patent ductus arteriosus (PDA) is a congenital heart defect – a structural heart problem that is present at birth. Patent ductus arteriosus is an abnormal connection between the aorta and the pulmonary artery in the heart.
Is Amplatzer device MRI compatible?
Magnetic resonance imaging (MRI) scans are generally acceptable, and your AMPLATZER PFO Occluder is compatible with imaging when using a 3-tesla MRI.
Are PDA clips MRI safe?
on-clinical testing demonstrated that the Nit-Occlud® PDA coil is MR conditional. A patient this device can be scanned safely immediately after pl nditions: Static magnetic field of 3 Tesla or less Maximum sp The maximum whole-body averaged specif W/kg (normal operating mode only) for 15 minutes of scanning.
What is Amplatzer device?
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.
Is PDA serious?
A small patent ductus arteriosus often doesn’t cause problems and might never need treatment. However, a large patent ductus arteriosus left untreated can allow poorly oxygenated blood to flow in the wrong direction, weakening the heart muscle and causing heart failure and other complications.
Is the Amplatzer duct occluder II a PDA?
The Amplatzer Duct Occluder II is engineered using 2 articulating discs and multi-layered mesh that conforms to most classifications of PDAs. The Amplatzer Duct Occluder II AS (additional sizes) is able to occlude a variety of duct sizes, or elongated ducts, while minimizing protrusion into the aorta and pulmonary artery.
What is the maximum absorption rate of an Amplatzer?
Through nonclinical 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 118μ tesla.
What are the symptoms of duct occluder implants?
Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted. Some forms of nickel have also been associated with carcinogenicity (ability to cause cancer) in animal models.
Can a Amplatzer migrate in a Mr environment?
The AMPLATZER™ device should not migrate in this MR environment. Nonclinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla.