With a variety of shapes, sizes and features that facilitate precise placement, our proven ASD occluders are designed specifically for ASD closure. Both designs offer the reliable performance and procedural simplicity and flexibility you expect from our products.
Thanks to innovative research, manufacturing and some special help from her mother, the Amplatzer™ Septal Occluder has made a huge difference in Bao’s life, giving her the ability to be there for her family.
Safety in numbers
- 98.5% closure rate with no significant residual shunt (less than 2 mm) at one-year follow-up1
- Low major and minor complication rates: Post-production and long-term based on two-year follow-up1,3
Demonstrated clinical experience
The Amplatzer Septal Occluder is an extensively studied transcatheter ASD closure device in the marketplace today with more than 17 years of demonstrated clinical experience. The following three studies, taken together, cover over 1,500 patient-years of device experience.1-3
1998–2001 US pivotal trial
This study was conducted to determine the safety and efficacy of transcatheter atrial septal defect closure involving 442 device-closure patients and 911.5 total patient-years of device experience.1
2004-2007 Magic Atrial Septal defect study
This study evaluated the initial safety and results of unrestricted multi-institution routine use of the Amplatzer Septal Occluder in 478 patients.2
2008-2012 Amplatzer Septal Occluder post-approval study
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
Atrial Septal Defects (ASD)
An atrial septal defect (ASD) is a hole in the septum between the atria. ASDs are one of the most common congenital heart defects seen in pediatric cardiology and often occur in conjunction with other cardiac defects.4,5
Amplatzer™ Septal Occluder
Minimally invasive transcatheter closure is the primary option for secundum atrial septal defects (ASD).4 The Amplatzer Septal Occluder is designed to appose the septal wall on each side of the defect and create a platform for tissue in-growth after implantation.
Designed for ASD closure
- Shaped-memory Nitinol mesh securely apposes both sides of the septal wall
- A wide waist centers the device and fills the ASD
- Polyester material promotes occlusion and tissue in-growth
- Device can be recaptured and redeployed for precise placement
Amplatzer Cribriform Multi-Fenestrated Septal Occluder
The Amplatzer Cribriform Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the closure of multi-fenestrated (cribriform) ASD.
Excellent product design
- Self-expanding, double-disc device designed for closure of multi-fenestrated atrial septal defects
- Matched disc diameters maximize coverage of multiple fenestrations
- Device can be easily recaptured and redeployed for optimal placement
- Nitinol and interwoven polyester promote occlusion and tissue in-growth
- 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.
- Everett, A. D., Jennings, J., Sibinga, E., Owada, C., Lim, D. S., Cheatham, J., … Ringel, R. (2009). Community use of the Amplatzer atrial septal defect occluder: Results of the multicenter MAGIC atrial septal defect study. Pediatric Cardiology, 30(3), 240-247. http://dx.doi.org/10.1007/s002...
- Turner DR, Owada CY, Sang CJ, Kahn M, Lim S (2017). Closure of secundum atrial septal defects with the Amplatzer septal occluder: a prospective, multicenter, post-approval study. Circ Cardiovasc Interv. 2017;10:e004212. DOI: 10.1161/CIRCINTERVENTIONS.116.004212.
- Moake, L., & Ramaciotti, C., Atrial Septal Defect Treatment Options (2005). AACN Clinical Issues, 16(2), 252-266.
- McMahon, C. J., Feltes, T. F., Fraley, J. K., Bricker, J. T., Grifka, R. G., Tortoriello, T. A.,…Bezold, L. I. (2002). Natural history of growth of secundum atrial septal defects and implications for transcatheter closure. Heart, 87(3), 256-259.