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

Not yet recruitingOBSERVATIONAL
Enrollment

75

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Pulmonary Artery Stenosis
Interventions
DEVICE

PALMAZ MULLINS XD™ Pulmonary Stent

The PALMAZ MULLINS XD™ Pulmonary Stent is indicated for the non-emergency treatment of pulmonary artery stenosis in pediatric patients who are at least 10kg in weight with two ventricle anatomy. The PALMAZ MULLINS XD™ Pulmonary Stent is a balloon-expandable, laser cut stent made from 316L stainless steel tubing. The stent is supplied unmounted and in five (5) nominal unexpanded lengths: 19 mm, 25 mm, 29 mm, 39 mm, and 59 mm.

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Congenital Cardiovascular Interventional Study Consortium (CCISC)

UNKNOWN

lead

Cordis Corporation

INDUSTRY

NCT07122518 - Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis | Biotech Hunter | Biotech Hunter