scholarly journals Results of the U.S. Food and Drug Administration Continued Access Clinical Trial of the GORE HELEX Septal Occluder for Secundum Atrial Septal Defect

2014 ◽  
Vol 7 (8) ◽  
pp. 905-912 ◽  
Author(s):  
Alexander J. Javois ◽  
Jonathan J. Rome ◽  
Thomas K. Jones ◽  
Evan M. Zahn ◽  
Craig E. Fleishman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Atrial Septal Defect ◽  
Drug Administration ◽  
Septal Defect ◽  
Food And Drug Administration ◽  
Secundum Atrial Septal Defect ◽  
Helex Septal Occluder ◽  
The U.S

Closure of a secundum atrial septal defect in two infants with chronic lung disease using the Gore HELEX Septal Occluder

2015 ◽  
Vol 26 (1) ◽  
pp. 79-83 ◽  
Author(s):  
Matt E. Zussman ◽  
Grace Freire ◽  
Shawn D. Cupp ◽  
Gary E. Stapleton
Keyword(s):  
Atrial Septal Defect ◽  
Lung Disease ◽  
Premature Infants ◽  
Chronic Lung Disease ◽  
Septal Defect ◽  
Right Atrial ◽  
Secundum Atrial Septal Defect ◽  
Atrial Septal Defect Closure ◽  
Significant Clinical Improvement ◽  
Helex Septal Occluder

AbstractChildren with a secundum atrial septal defect are usually asymptomatic and are referred for elective closure after 3–4 years of age; however, in premature infants with chronic lung disease, bronchopulmonary dysplasia, or pulmonary hypertension, increased pulmonary blood flow secondary to a left-to-right atrial shunt, may exacerbate their condition. Closure of the atrial septal defect in these patients can result in significant clinical improvement. We report the cases of two premature infants with chronic lung disease, who underwent atrial septal defect closure with the Gore HELEX Septal Occluder and discuss the technical aspects of using the device in these patients and their clinical outcomes.

Evaluation of the small-aperture intracorneal inlay: Three-year results from the cohort of the U.S. Food and Drug Administration clinical trial

2018 ◽  
Vol 44 (5) ◽  
pp. 541-556 ◽  
Author(s):  
John A. Vukich ◽  
Daniel S. Durrie ◽  
Jay S. Pepose ◽  
Vance Thompson ◽  
Corina van de Pol ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Small Aperture ◽  
The U.S
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