|No. of subjects who underwent implantation||137|
|White or Caucasian||92 (67.2)|
|Black or African American||8 (5.8)|
|Hispanic or Latino||17 (12.4)|
|Patient age, yrs|
|Mean (SD)||9.5 (10.4)|
|Mean (SD)||30.7 (22.7)|
|Body surface area|
|Mean (SD)||0.98 (0.48)|
|Defect size from balloon sizing, mm|
|No. of patients||134∗|
|Mean (SD)||13 (3.0)|
Values shown are number (%) unless otherwise indicated.
↵∗ The balloon sizing for 3 subjects was not recorded/documented at the time of implantation.