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.
Study summary
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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
\- Subjects \*should\* meet criteria as per the list of indications/contraindications in the Instructions for Use, though all subjects treated with the PALMAZ MULLINS XD™ Pulmonary Stent will be considered eligible and enrolled.
Primary outcome measure(s)
Technical Success (Successful use of the study device without additional, unplanned device or procedure-related surgery/re-intervention) — Start time of index procedure through time of discharge/study completion, usually within ~48 hours from end time of index procedure 1. Successful access, delivery and retrieval of the device delivery system,
2. Deployment and correct positioning of the device in the intended location, and
3. No need for additional, unplanned surgery or re-intervention related to the device or access procedure.
Patency (Angiographically-determined increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter) — Index procedure (start time to end time) Increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter determined by post-implant angiography.
Safety Outcome (Incidence of Treatment-Emergent Serious Adverse Events) — Time of enrollment (device implant during index procedure) through time of discharge/study completion, usually within ~48 hours from end time of index procedure Device or procedure-related, serious adverse events reported through time of hospital discharge, which meet any of the following criteria:
1. Led to a death,
2. Led to a serious deterioration in health of the subject, that either resulted in
1. Life-threatening illness or injury, or
2. Hospitalization (initial or prolonged) or
3. Disability or permanent impairment of a body structure or a body function or
4. Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function
3. Other Serious (important) Medical Events
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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