OCCLUDER
STRUCTURAL INTERVENTIONS
The primary treatment option for atrial septal defects (ASD) is percutaneous,
transcatheter closure, and Abbott’s Amplatzer™ Septal Occluder is the proven
standard of care2,5—with more than 20 years of global clinical experience in ASD closure.1
GREATER SAFETY COMPARED WITH SURGICAL CLOSURE
The Amplatzer™ Septal Occluder is the most studied transcatheter atrial septal defect (ASD) closure device available today, with over 25+ years of demonstrated clinical experience.1,2
The following 3 studies, together, cover over 1,500 patient-years of device experience.2-4
1,500
PATIENT-YEARS
U.S. PIVOTAL TRIAL: LOWER RATES OF ADVERSE EVENTS VS SURGERY2
This study was conducted to determine the safety and efficacy of transcatheter ASD closure involving 442 device-closure patients and 911.5 total patient-years of device experience.2 The U.S. Pivotal Trial revealed:
- An adverse event rate 3 times lower for Amplatzer Septal Occluder as compared to surgical closure
- No erosion events
| AMPLATZER™ SEPTAL OCCLUDER PATIENTS | |
|---|---|
| Procedure Attempt Success | 95.7% |
| Immediate Procedure Success | 97.6& |
| 24-hour closure rate | 96.7% |
| 6-month closure rate | 97.2% |
| 12-month closure rate | 98.5% |
| Major complications | 1.6% |
| Minor complications | 6.1% |
AMPLATZER SEPTAL OCCLUDER POST-APPROVAL STUDY3
This study is evaluating the long-term safety and efficacy of the Amplatzer Septal Occluder. The results below are from 1,000 patients reported in July 2011.3
| Procedural success rate | 97.9% |
| One-month closure rate | 98.5% |
| Two-year closure rate | 97.9% |
MAGIC ATRIAL SEPTAL DEFECT STUDY4
This study evaluated the initial safety and results of unrestricted multi-institution routine use of the Amplatzer Septal Occluder in 478 patients.4
| Procedural success rate | 96% |
| 24-hour closure rate | 99% |
The Amplatzer™ Portfolio App helps physicians determine which Amplatzer Structural Interventions device to use by suggesting applicable devices based on respective Instructions for Use.
TV
TV
Left Atrial Appendage Occlusion (LAAO)
Atrial Septal Defects (ASD)
Patent Foramen Ovale (PFO)
Anatomical overview of the heart
ASD Patient Story: Valeria
Echo course ASD
Amplatzer™ manufacturing video: nitinol
- Masura J, Gavora P, Formanek A, et al. Transcatheter closure of secundum atrial septal defects using the new self-centering Amplatzer septal occluder: initial human experience. Cathet Cardiovasc Diagn. 1997;42:388-393.
- Du ZD, Hijazi ZM, Kleinman CS, Silverman NH, Larntz K; Amplatzer Investigators. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol. 2002;39:1836-1844. doi: 10.1016/S0735-1097(02)01862-4.
- Turner DR, Owada CY, Sang II CJ, et al. Closure of secundum atrial septal defects with the Amplatzer Septal Occluder: a prospective, multicenter, post-approval study. Circ Cardiovasc Interv. 2017;10:e004212.
- Everett AD, Jennings J, Sibinga E, et al. Community use of the Amplatzer atrial septal defect occluder: results of the multicenter MAGIC atrial septal defect study. Pediatr Cardiol. 2009;30:240-247.