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
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.