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Combined prospective United States clinical study data for the GORE(®) HELEX(®) septal occluder device
1Miami Children's Hospital, Miami, Florida.
Insights
The GORE® HELEX® Septal Occluder demonstrated high safety and efficacy in repairing secundum atrial septal defects (ASD). This study confirms its effectiveness in a large cohort, achieving 93.0% clinical success at 12 months.
Area of Science:
- Cardiovascular Medicine
- Medical Devices
- Interventional Cardiology
Background:
- The GORE® HELEX® Septal Occluder is used for secundum atrial septal defect (ASD) repair.
- No prior reports aggregate clinical trial outcomes for this device.
Purpose of the Study:
- To summarize outcomes for all subjects receiving the GORE® HELEX® Septal Occluder in a prospective US clinical study.
- To evaluate the safety and efficacy of the device for transcatheter ASD repair.
Main Methods:
- A combined cohort of 435 subjects from four US clinical studies (1999-2009) was reviewed.
- Clinical success was defined as a composite of safety and efficacy at 12-month follow-up.
Main Results:
- Device efficacy (12-month closure) was 98.3% in all subjects and 99.5% in appropriately sized device recipients.
- Freedom from major adverse events through 12 months was 95.2%.
- A composite clinical success rate of 93.0% was achieved at 12 months.
Conclusions:
- This study represents the largest prospective, controlled data set for the GORE® HELEX® Septal Occluder.
- Clinical data reaffirm the safety and efficacy of the device for secundum ASD repair.
Objectives:
Our goal was to summarize the outcome for all subjects evaluated during a prospective clinical study in the United States with the GORE(®) HELEX(®) Septal Occluder for transcatheter repair of secundum atrial septal defects (ASD).
Background:
The GORE(®) HELEX(®) Septal Occluder is currently utilized for repair of secundum ASD. No previous reports are available that summarize the combined clinical trial outcomes for this device.
Methods:
In the United States between 1999 and 2009, 435 subjects were enrolled through the Feasibility, Pivotal, Continued Access, and Post-Approval Studies. All subjects enrolled through these studies were collectively reviewed as the "study cohort." Clinical success, defined as a composite evaluation of safety and efficacy, is reported for subjects at the 12-month follow-up period.
Results:
Of the 435 device subjects enrolled in the four clinical studies, 412 subjects were eligible for follow-up. Device efficacy, as represented by clinical closure at 12 months, was achieved in 98.3% of subjects, and in 99.5% of those receiving a device whose nominal diameter was greater or equal to twice the balloon sized defect diameter. Through 12 months following implantation, freedom from major adverse events was 95.2%. Together, these results yield a 93.0% composite clinical success at 12 months following the index procedure.
Conclusions:
The combined clinical study cohort represents the largest prospective, controlled clinical trial data set available for the GORE(®) HELEX(®) Septal Occluder. The clinical data presented in this report reaffirm the safety and efficacy of the GORE(®) HELEX(®) Septal Occluder when utilized for secundum atrial septal defect repair.
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