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Endeavor Sprint Zotarolimus-Eluting Coronary Stent System
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.
FDA-Cleared Indications
- The supplied FDA indication text states: software enhancements and updates to the Fourier Transform Near Infrared (FT-NIR) system used for incoming active pharmaceutical ingredient identification testing.
- That indication does not support a coronary stent indication and should be verified against the FDA PMA record before publication.
Clinical Applications
- The device type is used in PCI to treat selected coronary artery lesions by providing a drug-eluting scaffold.
- The stent releases zotarolimus locally to reduce neointimal tissue growth and the risk of restenosis.
- Use in coronary arteries should follow the verified labeling for the specific Endeavor Sprint model, lesion characteristics, vessel size, and patient population.
Reported off-label uses
- Use of coronary drug-eluting stents in certain small vessels, long lesions, bifurcations, or other complex coronary anatomy outside the device-specific labeled population may occur in clinical practice but is off-label when not included in the approved labeling.
- Use in noncoronary arteries is not an approved use for a coronary stent system and should not be inferred from this record.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- Verify the FDA PMA number, product code, indication, model, stent lengths, diameters, delivery-system profile, and compatibility requirements; the supplied FDA text appears inconsistent with this device name.
- Implantation is performed by interventional cardiology using fluoroscopic guidance, usually through radial or femoral arterial access, with antiplatelet therapy prescribed according to the treating clinician and current guidelines.
- Contraindications and precautions commonly include inability to take required antiplatelet therapy, significant uncorrectable bleeding risk, relevant coronary anatomy outside the labeling, and allergy or hypersensitivity to device materials or drug components.
- MRI conditions must be checked in the current Endeavor Sprint labeling. Coronary stents are often MR conditional rather than automatically MR safe, and the scanner-field and timing requirements must be followed.
- The stent is intended for permanent implantation; restenosis, thrombosis, fracture, migration, and loss of vessel patency remain possible complications.
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.