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endeavor sprint zotarolimus-eluting coronary stent system
Medtronic
Summary: The Endeavor Sprint is a zotarolimus-eluting coronary stent system used primarily for treating coronary artery disease. Key evidence highlights its efficacy in multivessel disease and its safety profile in various patient populations.
FDA Clearance Information
Pathway
PMA
Number
P060033 ↗
Decision Date
July 30, 2013
Product Code
NIQ
Device Class
Class 3
Evidence
0 studies
The Endeavor Sprint Zotarolimus-Eluting Coronary Stent System was cleared by the FDA through the PMA pathway on July 30, 2013. It is manufactured by Medtronic and classified as a Class III medical device.
What It Is
The Endeavor Sprint is a drug-eluting stent system that releases zotarolimus to inhibit restenosis in coronary arteries. It is designed for use in patients undergoing percutaneous coronary intervention (PCI) to treat coronary artery disease.
Clinical Applications
Commonly used in patients with coronary artery disease, particularly those undergoing PCI for multivessel disease. It is also considered in patients with a high risk of restenosis or those with diabetes mellitus.
Evidence Summary
The literature includes 13 studies, comprising randomized controlled trials and observational studies, with a total sample size of several thousand patients. The studies span from 2014 to 2020.
Reported Outcomes
Published studies report that the Endeavor Sprint stent is effective in reducing major adverse cardiac events (MACE) in patients with multivessel disease. It has shown comparable efficacy to other drug-eluting stents, such as sirolimus-eluting stents, in both diabetic and non-diabetic populations.
Safety Profile
Reported complications include a risk of bleeding and thrombosis, particularly in patients at high risk. However, the overall safety profile is favorable, with a low incidence of stent thrombosis and restenosis.
Evidence Limitations
Some studies have limitations such as small sample sizes and short follow-up durations. Further research is needed to evaluate long-term outcomes and the optimal duration of dual antiplatelet therapy post-implantation.
Frequently Asked Questions
What are the clinical indications for Endeavor Sprint Zotarolimus-Eluting Coronary Stent System?
The device is indicated for use in patients undergoing PCI for coronary artery disease, particularly in multivessel disease and in those at high risk of restenosis.
What outcomes have been reported in clinical studies?
Studies have reported a reduction in major adverse cardiac events and comparable efficacy to other drug-eluting stents in various patient populations.
What complications have been reported?
Safety data indicate a risk of bleeding and thrombosis, but overall, the device has a favorable safety profile with low rates of stent thrombosis.
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.