Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis

A Post-Approval Evaluation of the PALMAZ MULLINS XD™ Pulmonary Stent in the Treatment of Pulmonary Artery Stenosis (REALPASS)

The purpose of the clinical investigation is to characterize clinical outcomes and to assess the real-world use of the commercial PALMAZ MULLINS XD™ Pulmonary Stent.

The clinical study is a prospective, single-arm, multi-center, post-approval study of all consecutive subjects treated with the PALMAZ MULLINS XD™ Pulmonary Stent. The study will enroll a minimum of 35 subjects and a maximum of 75 subjects in up to 11 U.S sites or until the end of the 2-year enrollment period has been reached, whichever comes first.

The study will collect the performance and safety data of the PALMAZ MULLINS XD™ Pulmonary Stent through time of hospital discharge.

- Subjects *should* meet criteria as per the list of indications/contraindications in the Instructions for Use, though all subjects treated with PALMAZ MULLINS XD™ Pulmonary Stent will be considered eligible and enrolled.