Amplatzer Septal Occluder

Industry-Leading
Experience

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 20 years of demonstrated clinical experience.1,2

The following three studies, together, cover over 1,500 patient years of device experience.2-4

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 20 years of demonstrated clinical experience.1,2

The following three studies, together, cover over 1,500 patient years of device experience.2-4

 

U.S. Pivotal Trial: Lower Rates of Adverse Events vs Surgery2

While proving the occluder’s safety and effectiveness, the U.S. Pivotal Trial revealed:

  • An adverse event rate 3 times higher with surgical closure vs the Amplatzer occluder
  • No erosion events
     
OUTCOMES
(AVERAGE 25.6 MONTHS)
AMPLATZER SEPTAL OCCLUDER PATIENTS§SURGICAL CONTROL PATIENTS
12-month closure rate*98.5%100%
Major adverse events 1.6%5.2%
Minor adverse events6.1%18.8%


* A shunt ≤ 2 mm without the need for surgical repair
† Events that are life threatening, prolong hospitalization, or have long-term consequences or need for ongoing therapy
‡ Device embolization with percutaneous retrieval, cardiac arrhythmia with treatment, phrenic nerve injury, hematoma, other procedural adverse events, pericardial effusion requiring medical management, evidence of device associated thrombus formation without embolization (with or without treatment), marker band embolization without known sequelae
§ Mean age of closure for Amplatzer Septal Occluder group ~18; ~6 for surgical closure group

Amplatzer Septal Occluder Post-Approval Study3

The 2-year follow-up data are as follows:

  • Successful closure rate of 97.9%
  • Total adverse event rate of 4.6%
     
  • MAGIC Atrial Septal Defect Study4

    OUTCOMESRATE
    Procedure success rate*96%
    24-hour closure rate99.6%
    Major adverse events1.1%
    Minor adverse events§4.8%


    * Successful occluder implantation
    † Defined as no to a small residual shunt
    ‡ Includes device embolization with surgical removal
    § Includes procedure-related arrhythmias, device embolization with percutaneous retrieval, heparin over-dosage that required reversal, asymptomatic thrombus in the pulmonary artery that resolved with heparin therapy over 24 hours

  • Costs with Transcatheter ASD Closure vs Surgical Closure9

    One retrospective review study evaluated both hospital costs as well as wage loss for parents of pediatric patients between surgical vs transcatheter ASD closure.
     

     CATHERIZATION AS CLOSURESURGICAL ASD CLOSUREP VALUE
    Length of stay (days)1.3 ± 1.33.6 ± 1.6< 0.001
    Mortality00-
    Total charges$64,966 ± 30,275$90,000 ± 43,771< 0.001
    Wage loss$857 ± 173$2,536 ± 222< 0.001


    The authors noted that because technical proficiency with the transcatheter approach continues to improve, procedure times and radiation exposure are decreasing. Some centers perform catheter-based ASD closure with increasing reliance on echocardiographic guidance.

AP2947055-WBO Rev. A

References
  1. Masura J, 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.
  2. Amplatzer Septal Occluder IFU.
  3. Turner DR, 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.
  4. Everett AD, 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.
  5. DiBardino DJ, et al. Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database. J Thorac Cardiovasc Surg. 2009;137(6):1334-1341.
  6. Karamlou T, et al. The rush to atrial septal defect closure: is the introduction of percutaneous closure driving utilization? Ann Thorac Surg. 2008;86:1584–1591.
  7. Kazmouz S, et al. Transcatheter closure of secundum atrial septal defects. J Invasiv Cardiol. 2013;25:257-264.
  8. Crawford GB, et al. Percutaneous atrial septal occluder devices and cardiac erosion: a review of the literature. Catheter Cardiovasc Interv. 2012;80(2):157-167. doi: 10.1002/ccd.24347.
  9. Sanchez JN, et al. Lower hospital charges and societal costs for catheter device closure of atrial septal defects. Pediatr Cardiol. 2017;38:1365–1369. doi: 10.1007/s00246-017-1671-0.
     

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