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promus premier everolimus-eluting platinum chromium coronary stent system promus elite everolimus-eluting platinum coro
Boston Scientific
Summary: The Promus Premier is an everolimus-eluting stent designed for coronary artery disease treatment. It is primarily used to improve coronary blood flow. Key evidence highlights its enhanced radial strength and safety profile.
FDA Clearance Information
Pathway
PMA
Number
P110010 ↗
Decision Date
November 19, 2020
Product Code
NIQ
Device Class
Class 3
Evidence
0 studies
The Promus Premier stent received FDA clearance through the PMA pathway on November 19, 2020. Manufactured by Boston Scientific, it is classified as a Class III medical device.
What It Is
The Promus Premier is a drug-eluting stent that releases everolimus to prevent restenosis in coronary arteries. It is made from platinum chromium, offering improved conformability and radiopacity.
Clinical Applications
This stent is commonly used in patients with coronary artery disease to maintain vessel patency post-angioplasty. It is particularly beneficial in complex lesions requiring enhanced radial strength.
Evidence Summary
The literature includes randomized controlled trials and observational studies, with a focus on real-world applications. Approximately 7 studies span from 2018 onwards, evaluating safety and efficacy.
Reported Outcomes
Published studies report that the Promus Premier stent demonstrates improved radial strength and conformability compared to older stent models. Clinical outcomes indicate effective prevention of restenosis with a favorable safety profile.
Safety Profile
Reported complications include typical stent-related issues such as thrombosis and restenosis, though the incidence is low. The safety profile is consistent with other drug-eluting stents.
Evidence Limitations
Current evidence is limited by the lack of long-term follow-up data and the need for more diverse population studies. Further research is needed to assess long-term outcomes and safety in varied clinical settings.
Frequently Asked Questions
What are the clinical indications for Promus Premier stent?
The Promus Premier stent is indicated for use in patients with coronary artery disease to prevent restenosis and improve blood flow in coronary arteries.
What outcomes have been reported in clinical studies?
Studies report enhanced radial strength and effective restenosis prevention, with a favorable safety profile.
What complications have been reported?
Safety data indicate low incidence of thrombosis and restenosis, consistent with other drug-eluting stents.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.