What is a Amplatzer Cribriform occluder?
The AMPLATZER™ Cribriform Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the closure of multifenestrated (cribriform) atrial septal defects (ASD).
Is a PFO closure device metal?
Your doctor will choose an occluder device that is slightly larger than the size of the defect. Over time, the patient’s own tissue grows into and around the device. The Amplatzer® PFO occluder consists of two expandable discs with a connecting waist, all made of a nickel-titanium metal alloy.
Is ASD life threatening?
Severe cases of atrial septal defects may lead to life-threatening complications such as chest pain, irregular heartbeats (arrhythmias), abnormal enlargement of the heart, a “fluttering” of the heart (atrial fibrillation), and/or heart failure.
What is a CardioSEAL?
the CardioSEAL, a permanent implant, which is constructed of a metal. (MP35N) framework to which polyester fabric is attached, and. • the Delivery Catheter, a coaxial polyurethane catheter designed. specifically to facilitate attachment, loading, delivery and deployment of the Occluder to the defect.
What is a Cribriform device?
Device Description The AMPLATZER™ Multifenestrated Septal Occluder – “Cribriform” (Cribriform Occluder) is a self-expanding double-disc nitinol mesh occlusion device. The 2 discs are connected by a short waist. Polyester fabric is securely sewn to each disc to increase occlusion.
How will I feel after PFO closure?
Expect tenderness or a small bump (size of a quarter) at the procedure site. Bruising is also common at the procedure site. Possible sensations in the chest: palpitations, chest discomfort, or pressure. This is very common about 2 weeks to 6 weeks post closure; usually treatment is NOT required.
Does PFO make you tired?
Dr Ross Sharpe explains “The presence of a large PFO can be a cause of stroke but can also result in a myriad of clinical symptoms. These symptoms can include a feeling of breathlessness or fatigue performing normal day to day tasks, such as hanging out the washing or going for a jog.
What is the magnetic field of an Amplatzer?
A patient with an implanted AMPLATZER™ device can be scanned safely immediately after placement of the device under the following conditions: Static magnetic field of 3 tesla or less Spatial gradient magnetic field of 720 G/cm or less Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning
What do you need to know about Amplatzer plugs?
Tests performed by and data on file at Abbott. Lopera, Jorge E. “The Amplatzer vascular plug: review of evolution and current applications.” Seminars in interventional radiology. Vol. 32. No. 04. Thieme Medical Publishers, 2015. Amplatzer™ Vascular Plug and Vascular Plug II – Instructions for Use Amplatzer™ Vascular Plug 4 – Instructions for Use
Is the Amplatzer PFO occluder a medical device?
Three large clinical trials have confirmed the superiority of PFO closure to medical management in reducing risk of stroke recurrence. 2-4 One study, the RESPECT trial, 2 is notable for several reasons: The Amplatzer PFO Occluder set the standard, pioneering treatment with a device developed specifically for PFO closure.
When to use the Amplatzer PFO sheath size?
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 AMPLATZER™ PFO device size required would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins.