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AUTUS VALVE PIVOTAL STUDY

An FDA-approved clinical research study of a novel size-adjustable pulmonary heart valve (U.S. only).

The Autus Valve Pivotal Study is a prospective, single-arm, multi-center study to evaluate safety and effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement

The Autus Valve Pivotal Study is actively enrolling patients.

Please contact the enrolling study centers for any inquiries.

Enrolling centers are listed in clinicaltrials.gov

Study Overview >

THE AUTUS VALVE PIVOTAL STUDY IS A CLINICAL RESEARCH STUDY OF AN INVESTIGATIONAL DEVICE NOT APPROVED FOR USE OUTSIDE OF CLINICAL TRIALS IN THE US.

FINAL ELIGIBLITY FOR A PARTICULAR PATIENT IS BASED ON THE APPROVED PROTOCOL REQUIREMENTS AND THE JUDGMENT OF THE RESPONSIBLE PARTICIPATING CLINICIANS.

CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.

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