PIVOTALÂ STUDY OVERVIEW



50 PATIENTS
18 MONTHS TO 16 YEARS OF AGE
Patients aged 18 months to 16 years requiring pulmonary valve replacement
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*Inclusion and Exclusion Criteria apply.
UP TO 15 U.S. CENTERS
KEY INCLUSION CRITERIA*
Aged 18 months to 16 years
Subject has a native or repaired right ventricular outflow tract.
Subject has at least one of the following echocardiographic findings:
Severe pulmonary stenosis (defined as RV to PA peak instantaneous gradient ≥60 mmHg);
Moderate or greater pulmonary regurgitation
Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation.
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KEY EXCLUSION CRITERIA*
Subject requires valve replacement in a non-pulmonary position.
Subject has a prosthetic valve at other valve position or will need a prosthetic valve at other valve position (i.e., anticipate additional valve replacements needed within 3 years).
Subject has pulmonary arterial hypertension (defined as mean PA pressure ≥25 mmHg).
Subject has pulmonary atresia and major aortopulmonary collaterals.
Subject has significant peripheral pulmonary artery stenosis.
Subject has a known hypersensitivity to anticoagulants and antiplatelet drugs.