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https://www.structuralheartsolutions.com/us/index.php?id=120&L=0
AMPLATZER TM SEPTAL OCCLUDER AND DELIVERY SYSTEM INDICATION FOR USE The AMPLATZER TM 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 …
https://professional.sjm.com/~/media/pro/resources/ifu/amplatzer-us/sh-asd/600208-011_ASD_eIFU_Secure_amplatzer_septal_occluder_us.ashx
The AMPLATZER Delivery System is intended to facilitate the attachment, loading, delivery, and deployment of the AMPLATZER Septal Occluder device. See Figure 2 for the delivery system components. Indications for Use The AMPLATZER Septal Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the
https://www.structuralheartsolutions.com/us/index.php?id=131&L=0
The AMPLATZER TM Duct Occluder and 180° Delivery System were sterilized with ethylene oxide and are for single use only. Do not reuse or resterilize. Do not reuse or resterilize. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
https://www.cardiovascular.abbott/us/en/hcp/resources/mri-ready-resources/structural-heart-mri-safety.html
amplatzer™ septal occluder and delivery system 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.
https://www.accessdata.fda.gov/cdrh_docs/pdf/P000039b.pdf
Figure 1 AMPLATZER Septal Occluder Device and Delivery System 6. Alternative Practices or Procedures The only alternative to device closure of an ASD is open-heart surgery. Cardiac surgery that is required for closure of such defects is a major procedure that requires cardiopulmonary bypass. Surgery is relatively safe with a mortality of less than 1%.File Size: 102KB
https://www.myamplatzer.com/hcp/congenital-heart-defect-solutions/ventricular-septal-defects-vsd/
The AMPLATZER™ Muscular VSD Occluder and delivery system should only be used by those physicians trained in transcatheter defect closure techniques. Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. This includes the availability of an on-site surgeon.
https://www.myamplatzer.com/patients/
The AMPLATZER™ Muscular VSD Occluder and delivery system should only be used by those physicians trained in transcatheter defect closure techniques. Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device.
https://www.cardiovascular.abbott/us/en/hcp/products/structural-heart/amplatzer-pfo.html
The Amplatzer PFO Occluder’s unique design is a primary reason for its safety and efficacy. In addition, the occluder’s capability to be fully recaptured and fully repositioned allows physicians to confirm proper placement prior to final release of the device.
https://professional.sjm.com/~/media/pro/resources/ifu/amplatzer-us/sh-pda/600207-008_PDA_eIFU_clean_amplatzer_duct_occluder_us.ashx
The AMPLATZER 180° Delivery System is composed of a delivery sheath, dilator, loader, plastic vise, and delivery cable. 180° indicates the curve of the delivery sheath. Indications and Usage The AMPLATZER Duct Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).
https://manuals.sjm.com/~/media/manuals/product-manual-pdfs/f/c/fcba81dd-ae2f-46fb-9306-40d1418d6240.pdf
delivery system by AMPLATZER™ device size, or refer to Table 3 to select the delivery system with a sheath that has the correct inner diameter as indicated in the device’s instructions for use. 2. Prepare the delivery system for use: - Inspect the sterile pouch and verify that it is unopened and undamaged. Do not use the components if the sterile
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